Rise In Hemoglobin Research Articles

Comparative study of postpartum correction of anaemia by iron sucrose vs blood transfusion

Aim: The aim of the study is to know whether intravenous iron sucrose can be a better alternative in terms of safety and efficacy over blood transfusion in the treatment of anaemia in post-partum. Materials and methods: This are prospective study is conducted in obstetrics and gynaecology Department . All these women are randomly assigned (50 women total , 25 in each group) to receive either 2 doses of intravenous iron sucrose(Group A) or blood transfusion (Group B). Haemoglobin, hemocrit, mean corpuscular volume and serum ferritin estimation is done before treatment and after 1 wk. of correction in both groups to note the improvement in values and monitored for adverse reactions. Results: There is statically significant rise in haemoglobin , hemocrit , mean corpuscular volume , and serum ferritin levels when compared to baseline after 1 week of treatment in both groups. Statistically insignificant rise in mean Hb,Hct was observed when iron sucrose group is compared to blood transfusion group. Conclusion: Intravenous iron sucrose is safe , efficacious and cost-effective treatment for post-partum anaemia. It may be an attractive to blood transfusion which may be associated with minor and major reactions.

Intravenous ferric carboxymaltose versus iron sucrose in iron deficiency anemia of pregnancy

Iron deficiency is the most common nutritional deficiency worldwide. Anemia, defined by the World Health Organization as hemoglobin < 11 g/dl, is frequently seen in the antenatal period and affects 4-48% of women who give birth and severe anemia, with hemoglobin levels <9 g/dl .This study is to evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy.: A comparative, interventional, prospective study was carried out in 100 antenatal patients with Anemia (hemoglobin level between 5 to 9.5 gm/dl) in the department of obstetrics and gynecology, Government Medical College, Baroda, Gujarat, India from September 2017 to August 2018. The subjects were randomized in two groups. First group receiving 1000 mg of intravenous iron sucrose divided in five doses on alternate days (200 mg each) and Second group receiving 1000 mg of intravenous ferric carboxymaltose.: Maximum number of patients in our study were belonged to low socioeconomic group, significantly higher number of women achieved rise of hemoglobin >2gm/dl in FCM group, which was highly significant (p value <0.001). Mean rise of hemoglobin was 1.9 g/dl for FCM group and 1.66gm/dl for iron sucrose group, which was also significant. Serum ferritin level in ferric carboxymaltose group was rises more as compared to iron sucrose group. Unpaired‘t’ test was used to test the significance of rise and compare the rise between two groups.Ferric carboxymaltose is an efficient and better alternative to Iron Sucrose in treating iron deficiency anemia of pregnancy. It has an added advantage of single dose regime with lower side effects.

Change in Hemoglobin with Androgen and Low Dose Erythropoietin Versus Erythropoietin Alone in Patients of Anemia of Chronic Kidney Disease

Objectives: To determine the mean rise in hemoglobin with androgen and low dose erythropoietin versus erythropoietin alone in patients of anemia of chronic kidney disease. Methodology: A randomized control trial was conducted at a tertiary care hospital between October 2019 to April 2020. Both male and female from age >17years to 70 years with anemia of CKD as per operational definition were included. Patients with a history of blood transfusion in the last three months. Patients already on Erythropoietin therapy or those with uncontrolled hypertension BP >190/105 mm Hg at the time of study were excluded. Relevant data including demographic details, baseline hemoglobin was noted. Patients were randomly assigned to group A or group B by lottery method. Patients in group A were given 100mg of androgen (Nandrolone Decanoate) intramuscularly once weekly plus low dose of erythropoietin (2000 units twice weekly) subcutaneously for 6 months and patients in group B were given standard dose of erythropoietin (4000 units twice weekly) subcutaneously for 6 months. Rise in hemoglobin was recorded as per operational definition. Follow up was ensured by taking telephone contact. Data was recorded on pre-designed proforma. Results: Mean Hb levels after treatment were calculated as 12.48+1.20 in Group-A and 11.12+1.32 in Group-B, p value was calculated as 0.0001 showing a significant difference between the two groups, comparison of mean increase in Hb levels after treatment were calculated as 3.0+0.09 in Group-A and 1.72+0.67 in Group-B, p value was calculated as 0.0001 showing a significant difference between the two groups. Conclusion: We concluded that there was significantly greater rise in the mean hemoglobin with androgen plus low dose erythropoietin as compared to erythropoietin alone in treatment of anemia of chronic kidney disease. Nevertheless, further large-scale and multi-center studies will be needed to further explore the long-term efficacy and adverse effects of androgens among patients of anemia of chronic kidney disease. Keywords: Chronic kidney disease, anemia, androgen and low dose erythropoietin versus erythropoietin alone, mean increase

Blood Conservation Strategies in Adult Sickle Cell Patients on Chronic Transfusion Therapy: A Single Center Experience

▪Background: Adult sickle cell patients on chronic transfusion therapy (CTT) garnered special concern during the COVID-19 pandemic, when mass cancellation of blood drives threatened the national blood supply. In response, the American Society of Hematology proposed several strategies to decrease blood utilization, while maintaining adequate disease control for sickle cell patients on CTT. These included targeting a higher end hemoglobin S%, switching patients to simple transfusions when appropriate, and transitioning to alternative disease modifying therapies. There is little evidence to support the safety of altering exchange therapy regimens. Accordingly, at the Johns Hopkins Sickle Cell Center for Adults, a multidisciplinary team of clinicians and transfusion medicine specialists evaluated patients on a case by case basis to determine how their exchanges could be modified to accommodate for anticipated blood supply shortages. We describe our blood conservation efforts during the COVID-19 pandemic and resulting clinical outcomes for adult patients with sickle cell anemia (SCA).Methods: For inclusion in this IRB-approved retrospective study, patients received at least 7 monthly exchange transfusions between March 2019 and February 2020 and continued care through March 2021. Decisions regarding CTT were made prior to data collection. Modifications to chronic exchanges included increasing the fraction of cells remaining (FCR), decreasing the end hematocrit, or switching to a hemodilution method. Additionally, select patients transitioned to monthly simple transfusions if they were clinically stable, had a hemoglobin ≤ 7 g/dL, and had a persistently suppressed hemoglobin S% (≤ 30).We collected basic demographics, pre-exchange laboratory studies, and exchange parameters before and after each transfusion encounter in the year before (March 2019 - February 2020) and during (March 2020 - February 2021) the COVID-19 pandemic. Lastly, we recorded presentations to urgent care and the emergency department; and hospital admissions during each time period. We reported descriptive statistics for the cohort and compared outcomes using the Wilcoxon signed-rank test and Mann Whitney U test. We analyzed data using Stata/SE Version 16.1.Results: We identified 58 patients with SCA who qualified for inclusion (Table 1). Fifty-three patients remained on chronic exchange transfusions during the pandemic, and five were switched to simple transfusions. For patients who remained on chronic exchanges, most received conventional automated red cell exchange (RCE) prior to (85%) and during the pandemic (77%). Use of hemodilution increased (15% to 23% of patients). Forty-three patients experienced an increase in mean FCR (33.6 (SD 11.6) vs 37.7 (4.7), p = .00). Of those, 22 patients saw a concomitant decrease in mean end hematocrit (30.8 (1.7) vs 29.6 (1.1), p = .00). These changes resulted in a decline in the average number of units per procedure (8.6 (1.9) vs 7.3 (1.7), p = .00), which corresponded to 890 units conserved. Mean pre-transfusion hemoglobin values declined (9.4 (1.3) vs 9.2 (1.3), p = 0.01), but hemoglobin S%, reticulocyte count, and ferritin values were unchanged (p > 0.05). Acute care presentations and hospital admissions declined, which were likely spurred by concerns about COVID-19 infection (Table 2, p < 0.05).During the pandemic, three patients died, one of whom had been switched to simple transfusions. This patient experienced a consistent rise in hemoglobin S% until death. Two of the remaining patients on simple transfusions were switched back to automated RCE due to an increase in hemoglobin S% above goal (Figure 1).Conclusions: During the COVID-19 pandemic, we conserved red blood cell units through expanded use of hemodilution, higher FCR values, and switching some patients to simple transfusions. Patients who remained on exchanges maintained hemoglobin S% values near a goal of 30% without increasing iron burden. In contrast, the majority of patients who were switched to simple transfusions were unable to maintain goal hematologic parameters, and one patient died. Our data suggest that in a blood shortage crisis, changing the exchange procedure itself may be the safest means of conserving blood in a population of adult sickle cell patients; however longer follow-up is needed to ensure that these changes are safe. [Display omitted] DisclosuresLanzkron: GBT: Research Funding; Shire: Research Funding; Novo Nordisk: Consultancy; CSL Behring: Research Funding; Pfizer: Current holder of individual stocks in a privately-held company; Teva: Current holder of individual stocks in a privately-held company; Novartis: Research Funding; Imara: Research Funding; Bluebird Bio: Consultancy.

EP.TU.269Management of preoperative anemia with Iron Therapy in colorectal cancer patients- a Systematic Review and Meta-Analysis

Abstract Background Nearly half of colorectal cancer (CRC) patients are diagnosed with anemia at the initial assessment (Ferlay et al., 2015). Anemic patients require blood transfusion, which increases cancer recurrence (Acheson et al., 2012). Hence iron therapy for anemia correction reduces postoperative morbidity and mortality. Aims To review randomized controlled trials on iron therapy for preoperative anemia in CRC patients. Methodology Includes formulating a review question, analyzing, quantifying the inclusion and exclusion criteria, literature search, quality assessment, data extraction and data synthesis, bias rectification, results interpretation and summarizing the evidence. Cochrane Handbook of Systematic Reviews and acronym PICO has been used for formulating review questions and study design (O’Connor et al., 2011). Selection Criteria Systematic reviews and RCTs with higher level of evidence were included in this review Data Extraction Quality assessment and data collection were done using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta- Analysis) checklist. Data extraction and analysis done by REVMAN Manager (Higgins et al., 2011). Results Two trials reported that iron therapy reduces the need for blood transfusion, but with insignificant result. All three studies showed that hemoglobin rise occurs with iron therapy postoperatively. None of the studies analyzed the quality of life. Recommendations RCTs with larger sample size to be done for more relevant and accurate reports, aiming at the primary and secondary outcomes like morbidity, mortality and quality of life. Oral iron with fewer side effects has to be experimented for best efficacy.

Preoperative Single-Dose Intravenous Iron Formulation to Reduce Postsurgical Complications in Patients Undergoing Major Abdominal Surgery: A Randomized Control Trial Feasibility Study (PIRCAS Trial Pilot).

BackgroundPreoperative anemia is associated with an increased need for blood transfusion, complications, and prolonged hospital stay. Iron deficiency anemia (IDA) may be treated with oral or intravenous (IV) iron. IV iron repletes iron stores more rapidly. Its impact on perioperative blood transfusion, postoperative complications, patients’ recovery, and long-term quality of life is unclear. Newer agents, such as ferric carboxymaltose (FCM), are costly but have higher maximum approved doses and a very low incidence of anaphylactic-type reactions. This study aims to explore the feasibility of a randomized control trial to compare the preoperative treatment of IDA with IV FCM versus oral ferrous fumarate, in patients undergoing elective major abdominal surgery.Experimental designThis is an open-label pilot randomized controlled trial. A total of 30 adults with IDA scheduled for elective major abdominal surgery were recruited for the study. They were randomized into two groups to receive either oral iron or IV FCM. Primary outcomes are defined as the time from enrollment to study drug administration, recruitment rate, and follow-up rate up to three months. Secondary outcomes are hemoglobin rise from recruitment to surgery, perioperative blood transfusion, postoperative complications, EQ-5D-3L scores at baseline, and three months and adverse events related to IV FCM therapy.ResultsAll patients received study drugs within five days of enrollment; 30 patients were recruited within four months, 15 patients in each group. Two in each group were withdrawn for surgery postponement. All patients were followed up for three months and there was no crossover of patients. Per protocol, analysis was performed. No severe adverse events related to IV FCM therapy occurred. Both groups had similar baseline characteristics, similar hemoglobin rise from enrollment to the day of surgery [0.2 (+1.6) g/dL in the FCM group and 0.8 (+0.7) g/dL in the Oral Iron group, p=0.3] and similar mean units of perioperative blood transfused (recruitment to discharge) per patient [1.3 (+ 2.1) in the FCM group and 0.9 (+1.3) in the Oral Iron group, p=0.6]. Postoperatively, there was a similar hospital length of stay [11.5 (+13.6 days) in the FCM group and 9.0 (+9.8 days) in the Oral Iron group, p=0.6]; there were similar postoperative complications as reflected by the average Comprehensive Complication Index [12.8 (+19.6) in the FCM group and 22.6 (+30.7) in the Oral Iron group, p=0.3]; similar postoperative health-related quality of life as reflected by mean EQ-5D-3L scores at one month [70.4 (+21.8) in the FCM group and 84.5 (+12.1) in the Oral Iron group] and three months [80.0 (+18.4) in the FCM group and 85.9 (+10.7) in the Oral Iron group].ConclusionsA full-scale randomized controlled trial to evaluate the effectiveness of preoperative IV FCM compared to oral iron in patients with IDA undergoing major abdominal surgery is feasible.

Vitamin D and Blood Parameters.

Background: Vitamin D has a steroid- and an anabolic-resembling chemical structure. Vitamin D is essential for many processes in the human body after hydroxylation. Aims of the Study: To investigate the impact of 25-hydroxy-vitamin D plasma concentrations on the blood parameters number of erythrocytes, hematocrit, mean corpuscular hemoglobin and mean corpuscular volume. Methods: Serial assessments were done in 290 patients with multiple sclerosis and repeated after a mean interval of 245 days. A recommendation for vitamin D supplementation was given in case of a concentration lower than 20 ng/mL combined with a prescription of a formulation containing vitamin D but not vitamin K. Results: There was a fall of vitamin D in 119 subjects and a rise in 164, while no change appeared in 7 participants. When vitamin D values went down between both assessments moments, the computed increase of mean corpuscular haemoglobin was significantly lower compared with the rise of mean corpuscular haemoglobin associated with a vitamin D elevation. When vitamin D declined, the computed fall of mean corpuscular volume fall was significantly lower compared with the decrease of mean corpuscular volume, when vitamin D rose. Positive correlations were found between differences of vitamin D and mean corpuscular haemoglobin, respectively mean corpuscular volume. Inverse relations appeared between disparities of vitamin D and erythrocytes, respectively haematocrit. Conclusions: The elevation of vitamin D plasma levels provides enhanced preconditions for a better tissue oxygenation on a cellular level.

Study of Cigarette Smoking on Haematological Parameters and Lipid Profile in Vidharbha Region, India

Introduction: Cigarette smoke increases the risk of cardiovascular disease, such as coronary heart disease and peripheral vascular disease. Atherosclerosis, myocardial infarction, and stroke are also examples of ischaemic heart disease. Cigarette smoke contains more than 4,000 substances that have a negative or minimal effect on human health, including free radicals, nicotine, and the most important carbon monoxide in the pharmacy. Tobacco smoke kills 6 million people a year, many from lung cancer, chronic obstructive pulmonary disease (COPD), and cardiovascular disease (CVD). When opposed to never-smokers, smokers lose 10–15 years of life on average, and they begin to develop tobacco-related disorders such as coronary disease.&#x0D; Aim: Study of Cigarette Smoking on Haematological parameters and Lipid Profile in Vidharbha Region&#x0D; Material and Method: 25 subjects were smokers and 25 subjects were non-smokers. Patients went directly to the Observed Treatment Short-course focus in the Dept. of Medicine and Dept. of Respiratory, Datta Meghe Medical College and Shalinitai Meghe Hospital and Research Center.&#x0D; Result: Patients who were non-smokers and smokers were compared. Total cholesterol, triglycerides, LDL, and VLDL are statistically higher in smokers than non-smokers, but the same is true for HDL-cholesterol. Smokers had slightly lower HDL cholesterol than non-smokers.&#x0D; Conclusion: The smokers in this sample had dyslipidaemia as well as a large rise in haemoglobin and haematocrit. The RBC count rises as the rate of smoking rises, as it does in heavy smokers, and the altered lipid profile worsens. This dyslipidaemia in smokers can expose the vascular endothelium to potentially atherogenic lipoproteins, placing smokers at higher risk of developing atherosclerotic plaques and heart disease. As a result, quitting smoking early can alter these processes, which may prevent any major health risks.

Comparison of Erythropoietin alone with Erythropoietin plus oral Ascorbic Acid in the Treatment of Anemia in Chronic Kidney Disease Patients

Objective Of the Study: To compare efficacy of “Oral ascorbic acid in combination with Erythropoietin” with “standard dose of erythropoietin alone” in renal anemia in terms of mean hemoglobin rise.&#x0D; Introduction: Recombinant human erythropoietin (rhEPO) has a vital role in management of anemia in CKD (chronic kidney disease) patients. In the last decade, Ascorbic acid (AA) has emerged as a potential therapy to improve anemia probably by enhancing iron mobilization. We have conducted this study to compare the mean hemoglobin rise after treatment with standard dose erythropoietin alone with standard dose erythropoietin plus Oral ascorbic acid in CKD patients who were suffering from anemia.&#x0D; Materials &amp; Methods: A total of 70 patients of CKD with anemia, 18 to 70 years of age of both genders were included. Patients with laboratory proven iron deficiency anemia, obvious blood loss, pernicious anemia, hyperparathyroidism and contraindications for erythropoietin or ascorbic acid treatment were excluded. The patients which were selected randomly placed in two groups. Group A (erythropoietin alone) &amp; Group B (erythropoietin plus oral ascorbic acid), by using lottery method. Outcome variable like hemoglobin was measured at 2, 4 and 6 months.&#x0D; Results: Mean age was 48.90 ± 13.53 years. Male to female ratio was 1.6:1 with 43 (61.43%) males and 27 (38.57%) females. Mean pre-therapy hemoglobin was 9.40 ± 1.03 g/dl in the Group A while it was 9.42 ± 0.98 g/dl (p-value = 0.901) in Group B and mean post-therapy hemoglobin in the Group A was 9.34 ± 1.06 g/dl while in the Group B was 10.37 ± 1.16 g/dl with p value of 0.0002 which is statistically significant.&#x0D; Conclusion: The study concluded that standard dose erythropoietin plus Oral ascorbic acid in CKD anemia is more effective as compared to erythropoietin alone.&#x0D; Keywords: Chronic kidney disease, Erythropoietin, Ascorbic acid, Anemia.

A Multicenter, Open-Label, Pilot Study of Alisertib (MLN8237), a Novel Inhibitor of Aurora Kinase a, in Myelofibrosis

Background: Primary/Post-Essential/Post-Polycythemic Myelofibrosis (MF) is characterized by impaired maturation of GATA1 deficient megakaryocytes, which we hypothesize directly contribute to disease. (J Clin Invest 2017). The selective AURKA inhibitor alisertib (MLN8237) was shown to promote megakaryocytic maturation, amelioration of bone marrow fibrosis and lessen disease in animal models (Nat Med 2015).Methods: In an investigator sponsored multi-center pilot study (clinical trials.gov Identifier NCT 02530619), alisertib was administered to MF patients with at least DIPSS intermediate 1 risk who were in need of treatment, and were intolerant/refractory to or unlikely to benefit from JAK inhibitor therapy. Eligibility criteria also included an absolute neutrophil count ≥ 1 x109/L and platelet count ≥ 50 x109/L. Alisertib was provided by Takeda and administered at a dose of 50 mg by mouth twice daily for 7 days every three weeks. Adverse events (AEs) were monitored by common terminology criteria (Version 4.0). Laboratory correlative studies included assessment of the effects of alisertib and ruxolitinib on diagnostic samples and evaluation of changes in megakaryocytes and GATA1 expression in the bone marrow with therapy.Results:i) Patient characteristicsAs of June 2017, 19 patients (63% males; median age 72 years) have been enrolled, including 68% primary MF and 32% post PV/ET MF; 26% were DIPSS high and 74% intermediate-risk.11 (89%) patients had abnormal karyotype, including 7(64%) with unfavorable risk. Driver mutational frequencies were JAK2 58%, CALR 32%, and MPL 10%. Prior treatments included JAK inhibitors in 68% of patients.13 (68%) patients remain on treatment (median number of cycles=4; range 1-16). Median follow up of patients that were alive was 5 months (range; 1-10 months).ii) Safety dataTreatment related grade 4 hematological AEs included neutropenia, lymphopenia and thrombocytopenia seen in one patient each (5%). Grade 3 related hematological AEs included lymphopenia (n=4; 21%), anemia (n=3, 16%), febrile neutropenia (n=2, 11%), thrombocytopenia (n=1; 5%). The incidence of grade 3 related non- hematological AEs was as follows- vertigo (n=1; 5%), diarrhea (n=1; 5%); elevated lipase, alanine aminotransferase, and creatinine in one patient (5%) each. There was one unrelated grade 5 event -pneumonia with renal failure.iii)Preliminary efficacy dataa) Spleen response : 11(58%) patients had palpable splenomegaly ≥ 5 cm at time of study entry; 3 (27%) achieved ≥ 50% reduction in palpable spleen size.b) Erythroid response: 8 (62%) patients were transfusion dependent at baseline, of which none achieved transfusion independence. One patient displayed a durable rise in hemoglobin of ≥ 1g/dl.c) Leukocytosis/Thrombocytosis/Leukoerythroblastosis/LDH responses: 6 (32%) patients presented with leukocytosis and all (100%) had resolution of leukocytosis with treatment. Two patients (11%) had baseline thrombocytosis and both displayed ≥ 50% reduction in platelet count. Ten patients (53%) demonstrated leukoerythroblastosis and 2 (20%) displayed ≥ 50% improvement. All 19 patients had increased serum lactate dehydrogenase levels at time of study entry and 6 (32%) displayed ≥ 50% reduction with treatment.d) Symptom response: Of the 9 patients with constitutional symptoms at presentation, 5 (56%) reported improvement/resolution of symptoms. Moreover, 4 of 16 (25%) patients with at least moderate symptom burden achieved ≥ 50% reduction in the MF-SAF score.iv) Correlative studies: Alisertib, but not ruxolitinib, robustly promoted polyploidization and apoptosis of megakaryocytes derived from patient CD34+ cells at diagnosis. Morphological analysis of bone marrow revealed that alisertib led to improved megakaryocyte morphology and restoration of GATA1 staining (Figure 1).Conclusions: In this study we have reproduced, in the setting of a clinical trial, our previous preclinical observations that alisertib appears to normalize megakaryopoiesis in the MPNs. The reduction in peripheral counts is consistent with studies that suggest atypical MF megakaryocytes promote expansion of leukocytes. Although Alisertib had limited activity beyond demonstrated myelosuppressive activity in patients treated an average of four cycles, it was relatively safe. Updated results including overall response assessment and bone marrow review will be presented. [Display omitted] DisclosuresWatts:Jazz Pharmaceuticals: Consultancy, Speakers Bureau. Altman:Syros: Consultancy; NCCN: Other: Educational speaker; BMS: Consultancy; Celgene: Consultancy; Astellas: Consultancy; Ceplene: Consultancy; Janssen Pharmaceuticals: Consultancy; Novartis: Consultancy; ASH: Other: Educational speaker. Giles:Novartis: Consultancy, Research Funding.

Use of a Hemoglobin Substitute (HBOC-201) to Treat Acute Anemia in a Leukemic Patient with Anti-Vel Antibodies

BackgroundThe Vel-negative blood type is a rare autosomal recessive trait, occurring in 1 in 4000 persons. It is extremely difficult to supply blood to patients with anti-Vel antibodies, and the situation is even more challenging for Vel-negative patients with leukemia who may have high transfusion needs. There are case reports of treatment with hemoglobin substitutes in Jehovah's Witnesses and surgical patients. To the best of our knowledge, we report the first use of a hemoglobin substitute, HBOC-1201 (HemoPure) to treat a patient with refractory acute myeloid leukemia (AML) and anti-Vel antibodies.Case ReportOur patient is a 67-year-old Caucasian man with a one-year history of acute myeloid leukemia, refractory to multiple hypomethylator- and chemotherapy-based regimens. History is also significant for coronary artery disease with type 2 NSTEMI due to severe anemia. He has experienced prolonged pancytopenia due to leukemia and chemotherapy and required blood transfusions approximately weekly. Anti-Vel antibodies make transfusion of compatible blood challenging, and we utilized a hemoglobin transfusion threshold of 5 g/dL. Working with the American Red Cross and the American Rare Donor Program (ARDP), we transfused 44 units of Vel-negative blood over a one-year period, depleting the available Vel-negative units in North America. He presented to the hospital with productive cough and dyspnea. Initial labs revealed acute on chronic anemia with hemoglobin 3.5 g/dL. CT of the chest revealed right lower lobe pneumonia. Given critical anemia in the setting of pneumonia and possible sepsis, the patient needed immediate blood transfusion. Compatible Vel-negative blood was not available in North America. While awaiting availability of international blood units through the Red Cross and ARDP, we considered the choices of 1) transfusing incompatible blood or 2) administering a blood substitute. Because individuals with anti-Vel antibodies may develop severe acute hemolytic transfusion reactions when transfused incompatible blood, we chose to treat with HBOC-1201 (Biopure Corporation, Cambridge, MA), a bovine hemoglobin polymer that lacks a red blood cell membrane and thus red cell antigens such as Vel. We obtained an emergency IND from the FDA and local IRB approval. Three 32-gram units of HBOC-1201 were successfully transfused, with hemoglobin rise from 3.5 to 4.5 g/dL. Common adverse effects associated with the use of acellular hemoglobin substitutes include increase in concentration of methemoglobin and vasopressor effects leading to elevated blood pressure, fluid overload, and myocardial infarction. Our patient was monitored closely and tolerated the transfusion without any apparent adverse events.ConclusionDuring a challenging clinical situation, we successfully treated severe acute anemia in a patient with refractory AML and anti-Vel antibodies, using the acellular bovine hemoglobin-based blood substitute HBOC-1201, when compatible blood was not available. The infusion was tolerated without complications. Hemoglobin substitutes may be considered as bridging treatments in critically anemic patients such as those with hematologic malignancies when red blood cell transfusion is not an option. DisclosuresNo relevant conflicts of interest to declare.

Comparative Study of Intravenous Iron Sucrose Versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia during Pregnancy and Postpartum Period

Objectives: The present study aims at advantages of ferric carboxymaltose therapy over iron sucrose in iron deficiency anaemia of ante natal and postnatal patient. Methods: A prospective observational study was carried out at ACPM medical college during January 2017 to December 2017 for 50 antenatal and 50 postnatal women, total 100 women. Diagnosis of iron deficiency anemia done by proper history taking, examination, peripheral blood smear and blood indices. Baseline haemoglobin and serum ferritin levels were noted on first, eighth, fifteenth and thirtieth day of treatment with iron sucrose or ferric carboxymaltose for randomly selected 50 antenatal and 50 postnatal women. Results: The mean rise of haemoglobin value was 4.3 g/ L for ferric carboxymaltose and 4.0 g/L for iron sucrose in pregnant women. For postpartum women mean rise of haemoglobin was 4.9 g/L after treatment with ferric carboxymaltose and 4.4 g/L for iron sucrose. Conclusion: For the treatment of iron deficiency anaemia in pregnancy as well as postnatal women ferric carboxymaltose is safe, efficient and having many advantages over iron sucrose.

English

BACKGROUND Anaemia is one of the major public health problems in developing nations. Iron deficiency anaemia (IDA) is the commonest type of anaemia in pregnancy. Parenteral iron therapy is a recommended modality of treatment of IDA. Inj. Ferric Carboxymaltose (FCM) is a dextran free preparation which is safe, easy to deliver and better tolerated. A maximum of 1000 mg can be infused at a time. The present study was intended to assess the efficacy and safety of Inj. FCM in the treatment of iron deficiency anaemia in the second and third trimester. METHODS This prospective study was conducted at a tertiary care centre at Pune. Pregnant women with iron deficiency anaemia of moderate and severe grade were infused 1000 mg of Inj. FCM by longer infusion protocol. A total of 165 pregnant women were included in the study. The efficacy of Inj. FCM was monitored by the rise in the haemoglobin level at 03-, 06- and 08-weeks post infusion of FCM injection and serum Ferritin levels. The safety was assessed by analysing the adverse reactions. RESULTS No serious adverse reaction was recorded in any of the patients. The rise in haemoglobin (Hb) in second and third trimester of moderate and severe grade of anaemia was significant (P &lt; 0.001). The target level of 10 g / dl was achieved in every patient. Only 03 patients received blood transfusion and that was for obstetric indications. No blood transfusion was because of anaemia per se. The rise in serum ferritin level was also statistically significant (P &lt; 0.001). CONCLUSIONS Inj. FCM is an excellent modality to treat iron deficiency anaemia in pregnancy. It is safe and the rise of haemoglobin with correction of anaemia is satisfactory in a short span of time. In our country where only a handful of patients had regular antenatal check-up and non-compliancy and refractory anaemia is rampant, Inj. FCM is a big boon. KEYWORDS Iron Deficiency Anaemia, Inj. Ferric Carboxymaltose, Serum Ferritin, Blood Transfusion

MO540CARDIOVASCULAR OUTCOMES ASSOCIATED WITH ACHIEVED HAEMOGLOBIN LEVEL IN POOLED PHASE 3 STUDIES OF ROXADUSTAT IN NON-DIALYSIS-DEPENDENT PATIENTS WITH ANAEMIA

Abstract Background and Aims Randomised clinical trials evaluating anaemia correction using erythropoietin-stimulating agents (ESAs) in chronic kidney disease (CKD) patients have demonstrated an association between ESA use and increased risk of cardiovascular (CV) complications and mortality. Although the mechanism for this increased risk remains unclear, possibilities include rapid rates of rise (ROR) in haemoglobin (Hb), exposure to high ESA dose and dose escalation, a high Hb target range, and off-target effects of ESAs. Thus, current recommendations generally state that Hb levels should be maintained between 10 and 12 g/dL. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is used for the treatment of anaemia of CKD; roxadustat stimulates endogenous production of erythropoietin and enhances iron availability, thereby supporting red blood cell production. In this pooled analysis, we explored the relationship between 1) achieved Hb levels and 2) preliminary data for ROR of Hb and subsequent incidence rates of CV events in non–dialysis-dependent (NDD) CKD patients who received roxadustat. Method We analysed pooled data from four phase 3 studies in NDD patients (placebo-controlled: ALPS, ANDES, OLYMPUS; ESA-controlled: DOLOMITES) with anaemia of CKD who received any dose of roxadustat. The reported events occurred during the treatment period and within 7 days of the last dose of roxadustat. Incidence rates of adjudicated major adverse CV events (MACE: all-cause mortality [ACM], myocardial infarction, and stroke), MACE+ (MACE plus heart failure and unstable angina requiring hospitalisation), and ACM were examined relative to 1) most recent Hb level before the event and 2) the preliminary data for ROR of Hb within the 4 weeks of treatment immediately prior to the event. Results Overall, 2709 patients were randomised and received roxadustat. Incidence rates of MACE, MACE+, and ACM were 3- or 4-fold higher in patients with lower reported Hb levels (Hb &amp;lt;10 g/L) compared with those who achieved Hb ≥10 g/dL. Incidence rates of MACE, MACE+, and ACM were similar or lower in patients with a maximum rise of &amp;gt;2 g/dL in Hb within the 4-week period prior to the event compared to those with a change of ≤2 g/dL within the same period (Table). However, it should be noted that patient-exposure years (PEY) were low for the subgroup of patients with ROR &amp;gt;2 g/dL (∼3.3% of overall PEY), and patients with a decreasing Hb were included in the ≤2 g/dL/4 weeks subgroup. Conclusion In this analysis of roxadustat-treated patients with NDD CKD, incidence rates of MACE, MACE+, and ACM were lower in patients who achieved target Hb levels of 10-12 g/dL compared with patients who achieved Hb &amp;lt;10 g/dL. Risk of MACE, MACE+, or ACM did not appear to be associated with the proximal preliminary data for ROR of Hb; however, further characterisation of the ROR of Hb and ROR in relation to baseline Hb are warranted.

Red Cell Distribution Width As a Predictor of Mortality in Patients With Sepsis.

IntroductionSepsis is a common medical condition that is associated with very high mortality and, in survivors, long-term morbidity. Conventional inflammatory markers, such as CRP, erythrocyte sedimentation rate (ESR), and white blood cell count (WBC), have proven to have a limited utility in sepsis patients by virtue of their poor sensitivity and specificity for infections. Recently, the commonly used index of red cell distribution width (RDW) has been implicated as a prognostic marker in sepsis. This study aimed at assessing the role of RDW in predicting outcomes such as mortality in patients with sepsis and to study its role as a prognostic marker.MethodsThis was conducted as a prospective comparative observational study over a two year period between 2018 and 2020 in a tertiary care center in South India. In total, 60 adult patients above 18 years of age who were diagnosed to have severe sepsis and septic shock were selected to be part of the study. To find the survival probability on overall survival, Kaplan-Meier analysis was used and a comparison was done using the Log-rank test. To find the most significant predictors of mortality, cox regression analysis was applied.ResultsA total of 60 patients (n=60) were enrolled in this study out of which 30 (50%) patients had a rise in RDW and 30 (50%) patients had a fall in RDW. A total of 17 (28.3%) patients died during this study. In the rise in RDW group, there were 12 (40%) deaths while in the fall in the RDW group, there were five (16.7%) deaths. There was a statistically significant association found between mortality with rise and fall in RDW (p<0.05). A cox multivariate regression analysis demonstrated statistically significant associations between a rise in RDW (p<0.05, HR: 5.6, CI 1.4 to 21.9) and serum hemoglobin < 13.6 g/dL (p<0.05, HR: 3.6, CI 1.1 to 11.4) with mortality in this study. Kaplan-Meier analysis of rise and fall in RDW with survival trended towards better survival outcomes in the fall in the RDW group but was not significant (p=0.07).ConclusionWe found that an increase in RDW from baseline during the initial 72 hours after admission is significantly associated with adverse clinical outcomes including mortality. The mortality in the rise in the RDW group, as well as overall mortality, were significantly higher than the mortality in the reduced RDW group. Hence, serial RDW measurements could be used as a prognostic factor in severe sepsis and septic shock.

Is Endoscopic Band Ligation a Superior Treatment Modality for Gastric Antral Vascular Ectasia Compared to Argon Plasma Coagulation?

Background/AimsGastric antral vascular ectasia (GAVE) is a rare acquired vascular lesion of the gastric antrum. The most frequent presentation of GAVE is iron deficiency anemia. Endoscopic therapy is the mainstay of treatment. However, there is no consensus regarding the optimal treatment modality. MethodsA retrospective cohort study was performed on patients with GAVE, including patients receiving endoscopic therapy. Treatment was with either argon plasma coagulation (APC) or endoscopic band ligation (EBL). Basic demographic data, indication for index procedure, number of sessions, and pre- and post-hemoglobin levels were collected. The aim of the study was to compare outcomes across the two treatment modalities. ResultsOne hundred and seventeen diagnoses of GAVE were made. Sixty-two patients (53%) required endoscopic treatment for symptomatic GAVE (female, n=38, 61%; mean age of 74.4 years). Two hundred and eighteen procedures were performed during the study period. APC was performed (n=161, 74%) more frequently than EBL (n=57, 26%). Patients treated with APC at index required a median 5 subsequent therapeutic interventions (APC or EBL), while those treated with EBL at index required a further 2.9 treatments (EBL only) (p<0.05). ConclusionsAPC was the most common treatment modality employed. We demonstrate an increasing incidence of EBL. Patients treated with EBL at index treatment required fewer subsequent treatment sessions and had a greater mean rise in hemoglobin. This suggests a more effective endoscopic response with EBL.

Benefit of Iron Supplementation with Ferric Sodium EDTA (NaFe &amp;lt;sup&amp;gt;3+&amp;lt;/sup&amp;gt;-EDTA) in the Treatment of Anemia during Pregnancy in Democratic Republic of Congo (FERARI Study)

Background: Oral iron supplements, usually in the form of ferrous salts, are associated with gastric side effects, poor compliance and failure of anemia treatment. To make iron more bioavailable, reduce the gastric side effects and increase the patient compliance, newer iron form, Ferric Sodium EDTA, has become available on the market. Objective: To assess the change in hemoglobin level after iron supplementation with Ferric Sodium EDTA during pregnancy. Materials and Methods: This is a longitudinal study concerning 337 women attending antenatal care in maternity hospitals in the Democratic Republic of Congo from May to December 2020. The study included sociodemographic and anthropometric variables along with type of feed, hemoglobin level at recruitment and after three weeks of taking iron supplement with Ferric Sodium EDTA (Hemoforce Plus Zinc® syrup). For statistical analysis, we used t-test or ANOVA and chi-square test, the significance being stated at p Results: The frequency of pregnancy anemia was 51.4%. The mean hemoglobin value of the overall study group was 8.7 ± 0.5 g/dL. The mean maternal age and weight were 28.9 ± 6.2 years and 65.3 ± 11.7 kg, respectively. Most pregnant women (83.1%) had a diet consisting of food of plant and animal origin in equal proportions. Mean of Body Mass Index (BMI) was 24.6 ± 4.6 Kg/m2 and 44.3% were overweight and obese. The co-morbidities associated were malaria and intestinal parasitosis found in 45% and 5.9% of cases, respectively. After iron treatment with Ferric Sodium EDTA, the average hemoglobin level increased to 11.2 g/dL with mean gain of 2.5 g/dL (p Conclusion: Ferric Sodium EDTA as a novel iron formulation (Hemoforce Plus Zinc®) has shown a rapid increase in hemoglobin levels in pregnant women suffering from anemia. The speedy rise in hemoglobin is related to the property of Ferric Sodium EDTA to enhance the iron absorption by inhibiting the dietary iron inhibitors. Thus, Ferric Sodium EDTA should be used as an effective and promising iron supplement in pregnant women with iron deficiency anemia.

Role of ormeloxifene in AUB/HMB

Introduction: Heavy menstrual blood loss is defined as >80 ml of blood loss during menstruation. Abnormal uterine bleeding is abnormal menstruation as regards volume, regularity, frequency and duration of bleeding. Materials and Methods: A total of 100 patients of age group 25-45 years were included in this study. Patients were thoroughly investigated before inclusion. Exclusion criteria were any women with fibroid, adenomyosis, endometrial hyperplasia, breast cancer and coagulopathy. Patients were thoroughly investigated before therapy. Ormeloxifene was administered orally 60mg twice a week for 3 months followed by 60mg once a week for a month. Results: Amenorrhoea was 33% at 3 months follow up which is increased further to 42% at 4 months follow up. Similarly 44% women had scanty flow at the end of 4 months treatment. Comparison of clinical characteristics shows reduction in duration of menstrual blood loss and rise in haemoglobin (from 7.2 to 9 gm/dl, which is along with oral iron supplementation). Passage of blood also reduced considerably, although 7 (7.4%) women did not show good response. Conclusion: The study concluded that ormeloxifene is a good option as it is cheap, has twice weekly schedule, few side effects and efficacious in reducing the menstrual blood loss. Keywords: Heavy menstrual blood loss, Abnormal uterine bleeding, Fibroid, Adenomyosis, Ormeloxifene.

Anaemia in cardiac surgery - a retrospective review of a centre's experience with a pre-operative intravenous ironclinic.

Pre-operative anaemia is associated with higher rates of transfusion and worse outcomes, including prolonged hospital stay, morbidity and mortality. Iron deficiency is associated with significantly lower haemoglobin levels throughout the peri-operative period and more frequent blood transfusion. Correction of iron stores before surgery forms part of the first pillar of patient blood management. We established a pre-operative anaemia clinic to aid identification and treatment of patients with iron deficiency anaemia scheduled for elective cardiac surgery. We present a retrospective observational review of our experience from January 2017 to December 2019. One-hundred and ninety patients received treatment with intravenous iron, a median of 21days before cardiac surgery. Of these, 179 had a formal laboratory haemoglobin level measured before surgery, demonstrating a median rise in haemoglobin of 8.0g.l-1 . Patients treated with i.v. iron demonstrated a significantly higher incidence of transfusion (60%) compared with the non-anaemic cohort (22%) during the same time period, p<0.001. Significantly higher rates of new requirement for renal replacement therapy (6.7% vs. 0.6%, p<0.001) and of stroke (3.7% vs. 1.2%, p=0.010) were also seen in this group compared with those without anaemia, although there was no significant difference in in-hospital mortality (1.6% vs. 0.8%, p=0.230). In patients where the presenting haemoglobin was less than 130g.l-1 , but there was no intervention or treatment, there was no difference in rates of transfusion or of complications compared with the anaemic group treated with iron. In patients with proven iron deficiency anaemia, supplementation with intravenous iron showed only a modest effect on haemoglobin and this group still had a significantly higher transfusion requirement than the non-anaemic cohort. Supplementation with intravenous iron did not improve outcomes compared with patients with anaemia who did not receive intravenous iron and did not reduce peri-operative risk to non-anaemic levels. Questions remain regarding identification of patients who will receive most benefit, the use of concomitant treatment with other agents, and the optimum time frames for treatment in order to produce benefit in the real-world setting.

Real World Clinical Experience with Oxbryta Therapy in Individuals with Sickle Cell Disease

Background: Oxbryta is a recently approved drug for patients with Sickle Cell Disease (SCD), which decreases HbS polymerization, thus reducing red cell hemolysis and increasing hemoglobin concentration. It was first available for Expanded Access May 9, 2019 and received fast track approval for commercial use by the FDA on November 25, 2019. Objective: This analysis aims to gain insights to the real word experience for patients with SCD who are prescribed Oxbryta, identify barriers to its use, and measure health outcomes. Methods: Electronic medical records of 54 patients with SCD who were prescribed Oxbryta from January until June 2020 were reviewed and evaluated for data regarding demographics, initiation of treatment, hematological response, side effects, dosage modifications and terminal discontinuations. Results: A total of 54 patients were prescribed Oxbryta in the study period who were 96% (52/54) HbSS, and 4% HbSβ0 (2/54); 46% (25/54) male and 54% (29/54) female, and a mean age of 41 years (range 21-70). At time of initiation, 52% (28/54) of patients were taking hydroxyurea (HU). Indication for initiation of therapy was anemia and hemolysis. In this cohort, 65% of patients (35/54) were able to access drug with a mean time to obtain drug of 45 days (range 0-118 days). The most common barriers to obtaining drug were: requiring a prior authorization or appeal 9% (5/54), incomplete patient follow up 7% (4/54), missing documentation for application 6% (3/54) and high patient co-pay 6% (3/54). Of the 35 patients who started Oxbryta, 46% (16/35) experienced at least 1 side effect with 31% (11/35) reporting multiple side effects. The most common side effects reported were gastrointestinal distress (abdominal pain, nausea, vomiting and/or diarrhea) in 23% (8/35), dermatologic effects (itching and/or rash) in 17% (6/35), and experiencing an acute VOC or increase in daily pain in 11% (4/35). Twenty nine percent (10/35) of patients required a dose modification to address side effects (half who successfully continued the drug on a modified dosage), an additional 23% (8/35) of patients terminated usage of Oxbryta in response to side effects. After two to four weeks of taking Oxbryta 63% of patients had a hemoglobin increase of at least 1g/dl or greater. Conclusion: Oxbryta produces a substantial rise in hemoglobin for persons living with sickle cell and high baseline levels of hemolysis in about 60 % of patients, similarly to the results from the HOPE trial. However, there are significant barriers to access that require close follow up in the immediate period following prescription of the drug in order to minimize delays in access. Furthermore, in our cohort we observed a higher incidence of side effects than the 23% (900mg) -26% (1500mg) reported in the pivotal trial that led to its approval. While some individuals were able to be continue therapy after dose modifications, most discontinued therapy because of side effects. Figure Disclosures Minniti: CLS Behring: Consultancy; Roche: Consultancy; Emmaus: Consultancy; Forma: Consultancy; Global Blood Therapeutics: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Teutona: Membership on an entity's Board of Directors or advisory committees; Bluebird Bio: Other; Sodium Nitrate for SCD leg ulcers: Patents &amp; Royalties.