Change In Hb Level Research Articles

The impact of regular consumption of iron tablets on changes in hemoglobin levels of female adolescents with anemia in the Aksi Bergizi program: An experimental study

Background: Health problems that often occur in adolescent girls are anemia. The high incidence of anemia, despite the implementation of a blood supplementation tablet program for adolescent girls since 2016, led the government to initiate the Program Aksi Bergizi. Objectives: This study aims to explain the effect of the implementation of Aksi Bergizi on the regularity of blood supplement tablets consumption and changes in hb levels in anemic adolescent girls. Methods: This research is a quantitative study, which uses a quasi-experiment design with a control group pre-test post-test approach. The parallel design is used to compare between two groups. The population of anemic adolescent girls in class VII of SMPN 2 Sedati was 48 female students. The sample of this study was 48 respondents with total sampling. Data collection techniques by giving knowledge questionnaires, iron consumption monitoring checklists and checking Hb levels with easytouch Hb measuring instruments. The independent variable is the provision of Aksi Bergizi. While the dependent variable is the regularity of iron consumption and changes in Hb levels. Data analysis used Mann Whitney U Test with a significant value of p < 0.05. Results: The results showed that most respondents in the treatment group had good knowledge (41.7%), iron consumption became regular (79%) and hb levels increased by an average of 0.4 gr/dl after the nutritious action program. The results of this study did not apply to the control group who were not given Aksi Bergizi. In the bivariate test, there was an effect of nutritious action program on the regularity of iron consumption with a p value of 0.037 < α (0.05). In addition, there is an effect of Aksi Bergizi on changes in hb levels with a p value of 0.043 < α (0.05). It is concluded that the Aksi Bergizi affects the regularity of consumption of blood supplement tablets and changes in hb levels in anemic adolescent girls.

The clinical efficacy of combined ESA and Roxadustat treatment for renal anemia in hemodialysis patients with secondary hyperparathyroidism: A case series.

Pharmacological mechanism of Roxadustat in the treatment of renal anemia. To investigate the efficacy and safety of combined Roxadustat and erythropoiesis stimulator (ESA) treatment of renal anemia in hemodialysis patients with secondary hyperparathyroidism. A retrospective analysis was conducted on hemodialysis patients with renal anemia and secondary hyperparathyroidism treated with ESAs alone, who were admitted to our hospital from March 2022 to December 2022. The patients were treated with Roxadustat combined with ESAs for 3 months, during which oral iron supplementation was given, and the changes in Hb levels and laboratory-related indicators before and after the combined treatment were analyzed. The results showed that a total of 13 patients received combination therapy, with a significant increase in Hb compared to ESAs alone (t = -3.955, P = .002). The Hb qualification rate was 38.46%, and the ∆Hb response rate was 76.92%. The parathyroid hormone significantly decreased with a statistically significant difference (Z = -2.062b, P = .039). Hemoglobin (RBC), total iron binding capacity, and serum ferritin (male) were significantly increased compared to ESAs alone. Total cholesterol and low-density lipoprotein were significantly lower than ESAs alone. The differences in the changes in the above indicators were statistically significant (P < .05). There was no statistically significant difference in changes in other laboratory-related indicators (P > .05). No adverse reactions were observed during the combined treatment of 13 patients. The combination of Roxadustat and ESAs can effectively improve renal anemia in hemodialysis patients with secondary hyperparathyroidism, as well as improve indicators of hyperparathyroidism and blood lipid levels with high levels of safety. This combined treatment thus provides a new and safe treatment method for these patients.

#2595 Evolution of hemoglobin and serum uric acid levels after SGLT2i initiation in patients with and without diabetic nephropathy

Abstract Background and Aims Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are glucose-lowering drugs that inhibit glucose reabsorption in the proximal tubule, enhancing urinary glucose excretion. SGLT2i exhibit significant cardio- and renoprotective effects due to their capacity to increase diuresis and weight loss and reduce intraglomerular and blood pressure. Moreover, recent studies have described the potential of SGLT2i to improve additional cardiovascular risk factors, such as anemia or hyperuricemia. In this study, we aimed to describe the evolution of hemoglobin (Hb) and serum uric acid (SUA) levels in CKD patients with and without diabetic nephropathy before and after the initiation of SGLT2i therapy. Method CKD patients with and without diabetic nephropathy that were followed in the outpatient clinic of a tertiary referral academic hospital during January 2020 to September 2023 and that started SGLT2i therapy during that period were randomly recruited in the study. Patient characteristics, CKD staging, and levels of Hb and SUA before and after SGLT2i initiation were compared between groups. Hb and SUA levels were averaged considering all available laboratory controls during the last 12 months before treatment initiation and any available controls after treatment start. Results Demographic and clinical characteristics of enrolled patients are summarized in Fig. 1. Subjects with diabetic nephropathy were significantly older, more commonly hypertensive, presented worse kidney function, had received SGLT2i for a lengthier time and had lower hemoglobin values. We observed no change in hemoglobin levels after the initiation of SGLT2i in our sample, independently of diabetic nephropathy status or CKD stage (Fig. 2A, C). In contrast, SUA levels decreased significantly both in patients with and without diabetic nephropathy (Fig. 2B). This effect was observed across all the spectrum of CKD in our sample (Fig. 2D). Conclusion In our sample, SGLT2i initiation was associated with a significant decrease in SUA levels, both in patients with and without diabetic nephropathy and independently of CKD stage, which may help to explain its cardio- and nephroprotective effects. No change in Hb levels was observed, possibly due to a low prevalence of anaemia in our sample.

The efficacy and safety of molidustat for anemia in dialysis-dependent and non-dialysis-dependent chronic kidney disease patients: A systematic review and meta-analysis

ObjectiveMolidustat is a novel agent investigated for the treatment of anemia in both dialysisdependent (DD) and non-dialysis-dependent (NDD) patients. Its efficacy and safety are still unclear. MethodsWe searched five databases to identify randomized controlled trials comparing molidustat to erythropoiesis-stimulating agents (ESAs) or placebo in patients with anemia. ResultsSix studies containing 2025 eligible participants were identified. For NDD patients, the change in Hb levels from baseline (ΔHb) was significantly higher for molidustat than for placebo [mean difference (MD) = 1.47 (95 % CI: 1.18 to 1.75), P < 0.00001] and ΔHb was also significantly higher for molidustat than for ESAs [MD = 0.25 (95 % CI 0.09 to 0.40), P = 0.002]. For NDD patients, Δhepcidin was significantly lower for molidustat than for placebo [MD = −20.66 (95 % CI: −31.67 to −9.66), P = 0.0002] and Δhepcidin was also significantly lower for molidustat than for ESAs [MD = −24.51 (95 % CI: −29.12 to −19.90), P < 0.00001]. For NDD patients, Δiron was significantly lower for molidustat than for ESAs [MD = −11.85 (95 % CI: −15.52 to −8.18), P < 0.00001], and ΔTSAT was also significantly lower for molidustat than for ESAs [MD = −5.29 (95 % CI: −6.81 to −3.78), P < 0.00001]. For NDD patients, Δferritin was significantly lower for molidustat than for placebo [MD = −90.01 (95 % CI: −134.77 to −45.25), P < 0.00001]. However, for DD-CKD patients, molidustat showed an effect similar to that of ESAs on increasing the Hb level [MD = −0.18 (95 % CI: −0.47 to 0.11), P = 0.23], Δiron level [MD = 3.78 (95 % CI: −7.21 to 14.76), P = 0.5], Δferritin level [MD = 25.03 (95 % CI: −34.69 to 84.75), P = 0.41], and Δhepcidin level [MD = 1.20 (95 % CI: −4.36 to 6.76), P = 0.67]. For DD-CKD patients, compared with the placebo or ESA group, molidustat showed a significantly higher level on ΔTSAT[MD = 3.88 (95 % CI: 2.10 to 5.65), P < 0.0001] and a slightly increased level on ΔTIBC level [MD = 1.08 (95 % CI: −0.07 to 2.23), P = 0.07]. There was no significant difference in the incidence of severe adverse events (SAEs), death, and cardio-related adverse events between molidustat and the ESAs groups. ConclusionsMoricizine can effectively improves Hb levels in NDD patients and corrects anemia in DD patients without increasing adverse event incidence.

The Efficacy and Safety of Roxadustat for the Treatment of Posttransplantation Anemia: A Randomized Study

IntroductionRoxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, can stimulate erythropoiesis. Our objective was to evaluate the efficacy and safety of roxadustat for the treatment of post-transplantation anemia (PTA). MethodsA total of 150 adult renal transplant recipients who underwent PTA were randomized to either the experimental group or the control group. During the 12-week randomized phase, the experimental group was randomized to oral iron and roxadustat treatment, and the control group was randomized to oral iron treatment only. The randomized phase was followed by a 12-week extended treatment period in which all participants were prescribed roxadustat treatment according to hemoglobin (Hb) levels. All the participants were followed up every 4 weeks. The primary endpoints were the change in Hb levels and response rate throughout the randomized period. ResultsA total of 128 participants completed the randomized treatment period (90 in the experimental group and 38 in the control group). The mean Hb concentration at week 12 was 12.20 g/dL in the experimental group and 11.19 g/dL in the control group. A significantly higher proportion of participants who achieved Hb responses were in the experimental group than in the control group. Differences in serum iron, total iron-binding capacity (TIBC) and transferrin from baseline to week 8-12 were significant between the two groups. The adverse event profiles were comparable between the two groups. ConclusionsRoxadustat increased Hb in adult renal transplant recipients who underwent PTA, with an adverse event profile comparable to that of the control group.

A comparative study of ferric carboxymaltose and iron sucrose as a parenteral iron treatment in iron deficiency anemia during pregnancy in a tertiary care hospital

Background: Anemia from the Greek word (anhaima) meaning “without blood” is the deficiency of red blood cell and/or hemoglobin which result in reduced oxygen-carrying capacity of blood causing tissue hypoxia. Aims and Objectives: To study the efficacy and safety of intravenous ferric carboxymaltose (FCM) versus iron sucrose in the management of iron deficiency anemia in pregnancy. Materials and Methods: A prospective, single-center, comparative interventional randomized study was carried among 180 antenatal mother admitted to antenatal ward in the Department of Obstetrics and Gynaecology of Burdwan Medical College and Hospital, from July 1st, 2020, to December 30th, 2021. Results: A total of 180 patients, 90 patients in each FCM and iron sucrose group, were included in the study. There was significant (P=0.001) mean change in hemoglobin (Hb) level in both the groups from pre-treatment to 3 and 6-week post-treatment. There was also a significant (P=0.001) mean change in ferritin level in both the groups from pre-treatment to 3 and 6-week post-treatment. The mean change in Hb level and ferritin level was higher among patients of FCM compared to iron sucrose. The adverse reactions were lower among patients of FCM than iron sucrose. Conclusions: This study found that FCM is safer than iron sucrose. Treatment with FCM resulted in rapid replenishment of iron stores in pregnant women with significantly high rise of Hb and ferritin levels over a 6-week period with lesser adverse effects.

Effects of the Omicron variant of coronavirus disease 2019 on anaemia treatment for patients undergoing peritoneal dialysis.

Patients undergoing dialysis are at high risk for coronavirus disease 2019 (COVID-19). Haemoglobin (Hb) levels may be changed in patients infected with the Omicron variant of COVID-19 who are undergoing peritoneal dialysis (PD). Therefore, we aimed to explore the effect of anti-anaemia treatment on such patients. This study enrolled patients undergoing PD who were infected with the Omicron variant of COVID-19 at our centre between November 2022 and February 2023. We retrospectively analysed changes in Hb levels and explored the effectiveness of roxadustat and recombinant human erythropoietin (rhEPO) for patients infected with the Omicron variant of COVID-19. Among 125 enrolled patients, 83 (66.4%) were infected with the Omicron variant and 75 (90.4%) patients mainly experienced mild or moderate disease. During infection, C-reactive protein (CRP) levels were higher than those before infection (p < .001). Additionally, their CRP levels were negatively correlated with Hb levels (p = .002). However, Hb levels were decreased 1 month after infection (109.61 ± 10.64 g/L vs. 115.69 ± 12.04 g/L; p < .001). The roxadustat treatment group did not exhibit significantly decreased Hb levels 1 month after infection (114.57 ± 14.11 vs. 117.51 ± 10.74 g/L; p = .225). Conversely, the rhEPO treatment group experienced a mild decrease in Hb levels (108.69 ± 11.20 vs. 115.03 ± 12.23 g/L; p = .001). Ferritin levels increased in both groups during infection (p = .495). Two months after infection, ferritin levels (median, 205.0 ng/mL) were significantly decreased compared with during infection (median, 377.4 ng/mL) (p < .001) in the roxadustat treatment group. Roxadustat was effective than rhEPO for treating anaemia in patients undergoing PD who were infected with the Omicron variant of COVID-19.

Cost-effectiveness analysis of parenteral iron therapy compared to oral iron supplements in managing iron deficiency anemia among pregnant women.

This study compared the clinical efficacy and cost-effectiveness of parenteral iron, using intravenous iron sucrose (IVIS) therapy against the standard regimen of oral iron (OI) therapy for managing iron-deficiency anemia (IDA) among pregnant women in a natural primary care setting in Gujarat. A prospective cost-effectiveness study was conducted in natural programme setting wherein 188 pregnant women in their 14 to 18weeks with moderate and severe anemia women enrolled from two districts of Gujarat, and 142 were followed up until the post-partum phase. The intervention group comprised of 82 participants who were administered IVIS, while the comparison group comprised of 106 participants who were put on OI therapy. Hemoglobin (Hb) levels were measured at periodic intervals, first during enrollment and then during each month of pregnancy period and finally on the 42nd day of the post-natal period. Change in mean Hb level from baseline was the primary outcome, while the incidence of morbidity and mortality was a secondary outcome measure. The intervention group showed a significant incremental mean change in Hb level from 8.2g/dl to 11.45g/dl at the fourth follow-up, while the control group's mean Hb level reduced from 9.99g/dl to 9.55g/dl. The discounted cost per beneficiary for IVIS was US$ 87, while that for OI was US$ 49. The incremental cost-effectiveness ratio (ICER) was US$ 9.84, which is 0.049% of India's per capita GDP. IVIS therapy was more clinically effective and cost-effective than OI therapy among pregnant women for management of moderate and severe anemia.

A new knotless parametrial tissue ligation technique for safe total laparoscopic hysterectomy.

Parametrial tissue ligation during total laparoscopic hysterectomy (TLH) is important in large uteri with large vessels. A retrospective study was performed at Asan Medical Center for comparing TLH performed with a new knotless parametrial tissue ligation method and conventional laparoscopic-assisted vaginal hysterectomy (LAVH) from March 2019 to August 2021. For TLH, after anterior colpotomy, the parametrial tissue was ligated by anchoring the suture and making a loop in one direction three times using 1-0 V-LocTM 180 (Covidien, Mansfield, MA, USA) suture. Subsequently, the cranial part of the loop was cut using an endoscopic device. A total of 119 and 178 patients were included in the TLH and LAVH groups, respectively. The maximal diameter of the uterus was larger in the TLH group (106.29±27.16 cm) than in the LAVH group (99.00±18.92 cm, P=0.01). The change in hemoglobin (Hb) level was greater in the LAVH group than in the TLH group (P<0.001). The weight of the removed uterus was greater in the TLH group than in the LAVH group (431.95±394.97 vs. 354.94±209.52 g; P=0.03). However, when the uterine weight was >1,000 g, the operative times and change in Hb levels were similar between the two groups. In both groups, no ureteral complications occurred during or after surgery. Knotless parametrial tissue ligation using 1-0 V-LocTM 180 suture in TLH can be safely applied, even in cases with large uteri, without increased risks of ureteral injury or uterine bleeding.

Temporal trends of hemoglobin among pregnant women: The Mutaba’ah study

Background Low hemoglobin (Hb) level is a leading cause of many adverse pregnancy outcomes. Patterns of changes in Hb levels during pregnancy are not well understood. Aim This study estimated Hb levels, described its changing patterns across gestational trimesters, and identified factors associated with these changes among pregnant women. Materials and methods Data from the ongoing maternal and child health cohort study–The Mutaba’ah Study, was used (N = 1,120). KML machine learning algorithm was applied to identify three distinct cluster trajectories of Hb levels between the first and the third trimesters. Descriptive statistics were used to profile the study participants. Multinomial multivariable logistic regression was employed to identify factors associated with change patterns in Hb levels. Results The three identified clusters–A, B and C–had, respectively, median Hb levels (g/L) of 123, 118, and 104 in the first trimester and 119, 100, and 108 in the third trimester. Cluster ’A’ maintained average normal Hb levels in both trimesters. Cluster ’B’, on average, experienced a decrease in Hb levels below the normal range during the third trimester. Cluster ’C’ showed increased Hb levels in the third trimester but remained, on average, below the normal range in both trimesters. Pregnant women with higher gravida, diabetes mellitus (type 1 or 2), nulliparity or lower level of education were more likely to be in cluster ’B’ than the normal cluster ’A’. Pregnant women who reported using iron supplements before pregnancy or those with low levels of education. were more likely to be in cluster ’C’ than the normal cluster ’A’. Conclusion The majority of pregnant women experienced low Hb levels during pregnancy. Changes in Hb levels during pregnancy were associated with parity, gravida, use of iron before pregnancy, and the presence of diabetes mellitus (type 1 or 2).

Video Education of Iron Supplements and Pregnancy Nutrition to Increase Knowledge, Adherence, and Hemoglobin Level

Background: Pregnancy is a very important period, the state of the mother and fetus are related to one another. While pregnant women are often found to have iron deficiency anemia. One of the efforts to overcome the problem of anemia in pregnant women is by giving iron supplements. However, in Riau Province pregnant women who received FE3 decreased, namely in 2018 as much as 79% decreased to 65% in 2019. Therefore, an educational method is needed to increase knowledge, and adherence to taking iron supplements, and hemoglobin (Hb) levels in pregnant women. Objectives: To increase knowledge and adherence of taking iron supplements and hemoglobin (Hb) levels in pregnant women. Methods: This study is a pre-experimental study with one group pretest and post-test to evaluate the effect of nutrition education with video media on knowledge, adherence to taking iron supplements, and Hb levels in late-trimester pregnant women. The educational videos include material on the importance of taking iron supplements, how to consume them, and balanced nutrition for pregnant women. Result: There is a statistically significant difference between the knowledge and the adherence of pregnant women taking iron supplements before and after treatment or intervention with a significance value of 0.000 (&lt;0.05). Changes in Hb levels before and after treatment or intervention in the form of Educational Video for Iron Supplements (TTD) and Nutrition for Pregnant Women did not show a statistically significant difference with a significance value of 0.085 (&gt; 0.05).Conclusion: Educational videos on iron supplements and nutrition for Pregnant Women affect knowledge and adherence of pregnant women taking iron supplements.

Safety and Efficacy of Mitapivat in Adult Patients with Erythrocyte Membranopathies (SATISFY)

Background: Membranopathies encompass hemolytic disorders arising from genetic defects in erythrocyte membrane proteins and include hereditary spherocytosis and stomatocytosis. Congenital dyserythropoietic anemia type II (CDA II) is associated with SEC23B gene variants and its phenotype may be similar to hereditary spherocytosis. Anemia with or without the need for chronic transfusion, jaundice, splenomegaly, iron overload are complications common in both hereditary membranopathies and CDA II. Current treatment options for membranopathies and CDA II 1, apart from splenectomy, are primarily supportive. Mitapivat, an investigational pyruvate kinase-R (PKR) activator, has demonstrated efficacy in improving anemia and reducing hemolysis in adult patients with PK deficiency, thalassemia, sickle cell disease, and a mouse model of hereditary spherocytosis. Study Design and Methods: This study (NCT05935202) is an investigator initiated, prospective, multicenter, single-arm phase 2 trial. The study will be conducted in the European Union in Denmark and The Netherlands. It is the first clinical study in the context of the European Reference Network EuroBloodNet and will be sponsored by its closely associated non-for-profit EuroBloodNet Association. A sibling study in Toronto, Canada will be registered separately, and data will be pooled in a prespecified statistical analysis plan. The study will include approximately twenty-five adult patients (aged 18 years and older) diagnosed with a membranopathy or CDA II. Diagnosis must be confirmed genetically. Average hemoglobin concentration (Hb) must be less than 13.0 g/dL for males and 11.0 g/dL for females. Patients with average Hb &amp;gt;10.0 g/dL for males and females at screening must meet at least one of the following additional criteria: Splenomegaly, fatigue attributed to hemolysis, or paraclinical hemolysis. Adequate organ function is required. Patients cannot be included if they have a diagnosis of PK deficiency or if they have received red blood cell (RBC) transfusions (≥5 units the last 12 months or any within the last 3 months). During the 8-week Dose Escalation Period, subjects will receive an initial dose of 50 mg mitapivat twice daily (BID). Based on safety and changes in Hb levels, dosing may be increased to 100 mg BID at week 4. Patients who tolerate mitapivat may be eligible to continue in two consecutive 24-week Fixed Dose Periods, with an interim analysis in between the two fixed dose periods. The primary objective of this study is to evaluate the safety of mitapivat, assessed through the occurrence of treatment-emergent adverse events. Secondary objectives include assessing the effects of mitapivat on Hb concentration (≥1.0 g/dL increase sustained at two scheduled visits), hemolysis, erythropoiesis, patient-reported outcome measures, and spleen size. Exploratory endpoints include enzyme activity and stability of PK, Hb oxygen affinity, proteomics and metabolomics. To assess how activation of PK will impact RBC function we will measure RBC deformability (osmotic gradient ektacytometry and cell membrane stability) in whole blood and in different RBC subpopulations. Acknowledgement: This project is carried out within the framework of European Reference Network on Rare Haematological Diseases (ERN-EuroBloodNet)-Project ID No 101085717. ERN-EuroBloodNet is partly co-funded by the European Union within the framework of the Fourth EU Health Programme. The study is funded by a grant from Agios Pharmaceuticals.

Efficacy and Safety of Single Agent Proximal Complement Inhibitors in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients with Residual Anemia Despite of Adequate Terminal Complement Inhibitor Use

Background: Introduction of C5 inhibitors is a major advancement in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) patients. First Eculizumab and then Ravulizumab significantly improved anemia by controlling intravascular hemolysis (IVH), reduced thrombosis risk, improved quality of life and prolonged survival. However, a significant proportion of PNH patients remain anemic with transfusion dependence despite maximal C5 inhibition due to C3 mediated residual extravascular hemolysis (EVH). Recently two randomized, open label, controlled trials with proximal complement inhibitors were studied in this patient population comparing against C5 inhibitors as single agents with excellent results. Here we compare efficacy and safety data of proximal complement inhibitors pegcetacoplan (C3 inhibitor), Iptacopan (factor b inhibitor) based on published or presented data. Methods: We compared the efficacy and safety data of randomized portion of PEGASUS and APPLY-PNH trials. PEGASUS trial is a phase 3, randomized, open label, active-comparator controlled trial with Pegcetacoplan (a pegylated pentadecapeptide that targets C3) compared efficacy and safety against eculizumab in PNH patients with Hb &amp;lt;10.5 despite of treatment with Eculizumab (Hillerman, et al NEJM 2021;384). Primary end point of the study was mean change in Hb level from baseline to week 16. APPLY-PNH is an open label randomized, multicenter phase 3 trial compared Iptacopan 200 mg BID (oral factor b inhibitor) monotherapy with standard of care C5 inhibition therapy. (Regis P. de Latour et al. Blood (2022) 140 (Suppl 2): LBA-2). Primary end points of the trial were Hematological response defined as an increase in Hb of ≥ 2 g/dL from baseline and Hb ≥ 12 g/dL in absence of transfusions. Secondary end points included number of clinical and hematological markers of hemolysis and safety. Results: Summarized in table 1. PEGASUS trial included 80 patients with 41 in pegcetacoplan arm and 39 in Eculizumab arm. APPLY-PNH included 97 patients with 62 in Iptacopan arm compared to 35 in standard of care anti C5 therapy. Majority of baseline characteristics were similar between two studies. Mean age in both studies was around 50 years and close to 2/3rd of patients in each study were females. Median duration of prior C5 therapy was between 3-4 years in both studies. More than half of patients in both studies required PRBC transfusions in preceding months prior to enrollment. Baseline mean Hb was between 8-9 g/dL, LDH between 250-300 U/L, mean absolute retic count (ARC) 190-200x109/L. Both studies showed superiority in change from baseline Hb with +2.69 g/dL in PEGASUS trial with all available data regardless of transfusion events and +3.63 in APPLY-PNH trial. Both studies showed either noninferiority or superiority in freedom from transfusions and change in ARC. Interestingly, LDH change was not significant in both studies. Change from baseline fatigue FACIT-score was numerically better but not tested in PEGASUS trial and was superior in APPLY-PNH. No major vascular events or serious infections by encapsulated bacteria were reported in either study. Breakthrough hemolysis was reported in 4 out of 40 patients in PEGASUS trial that led to treatment discontinuation in 3 patients and 2 out of 62 patients in APPLY-PNH trial, however none of them required treatment discontinuation. Conclusions: PEGASUS and APPLY-PNH trials showed that in patients with persistent anemia despite C5 inhibitor therapy, proximal complement inhibition with either pegcetacoplan (C3 inhibitor) or Iptacopan (factor b inhibitor) as a single agent showed significant improvement in Hemoglobin with higher rate of transfusion independence with control of extra vascular hemolysis while maintaining intravascular hemolysis control with no serious infections. These studies represent another major advancement in the management of PNH patients. Long term follow up is needed regarding safety and to identify better ways to manage breakthrough hemolysis in patients on proximal complement inhibitors.

Relevance of haemoglobin monitoring in apheresis plasma donors: A retrospective cohort study in Québec, Canada.

Systematically measuring pre-donation haemoglobin (Hb) levels might be overly cautious for apheresis plasma donation, since plasmapheresis entails a small loss of red blood cells. We explored the association between the frequency of apheresis plasma donation and capillary blood Hb levels. This retrospective cohort study included donors who gave apheresis plasma at least twice between 24 October 2020 and 23 October 2022 in Québec, Canada. Results were stratified by sex and analysed with linear repeated-measure mixed models with random intercepts. In total, 9535 men (mean age = 46.7 years) and 9409 women (mean age = 41.1 years) made ≥2, but no more than 16 apheresis plasma donations. Over an average of 9.2 months of observation, men maintained Hb levels well above the Hb deferral threshold, and their Hb levels decreased by only 0.17 g/dL between the 1st and 15th donation return (p < 0.0001). Over an average of 9.0 months of observation, women also maintained adequate Hb levels, and their Hb levels decreased by 0.08 g/dL between the 1st and 15th donation return. The frequency of apheresis plasma donation was not associated with clinically meaningful changes in Hb levels, neither in men nor in women. This evidence questions the relevance of systematically monitoring Hb for apheresis plasma donation, at least for donation frequencies of ≤7-8 times per year. However, an adverse impact of plasmapheresis on Hb levels cannot be ruled out for individuals donating more frequently or for longer than ~9 months.

Bone wax reduces blood loss after total hip arthroplasty: a prospective, randomized controlled study.

Previous studies have demonstrated the efficacy of bone wax in reducing blood loss in various orthopedic surgeries. However, the effect of bone wax on total hip arthroplasty (THA) remains unclear. The objective of this study was to assess the efficacy of bone wax in THA. We enrolled 104 patients in this randomized controlled trial. These patients were randomized (1:1) to either the bone wax or control group. The primary outcome was total blood loss after THA. The secondary outcomes included serum hemoglobin (Hb) level, change in Hb level, lower limb diameters on the first and third postoperative day (POD), range of motion at discharge, length of postoperative hospital stay, and adverse events. Patients in the bone wax group had significantly lower total blood loss on PODs 1 and 3 (p < 0.05). Moreover, patients in the bone wax group performed better in terms of postoperative serum Hb level, change in Hb level on PODs 1 and 3, and length of postoperative hospital stay (all p < 0.05). Patients in the bone wax group did not experience any bone wax-related adverse events. Bone wax administration in THA significantly reduced perioperative blood loss. Therefore, bone wax is promising for optimizing blood-conserving management protocols in THA. [https://clinicaltrials.gov/], identifier [ChiCTR2100043868].

Tranexamic acid can reduce blood loss in adolescent scoliosis surgery: a systematic review and meta-analysis

BackgroundTranexamic acid (TXA) has been widely used in orthopedic surgery, but its efficacy in adolescent scoliosis (AS) surgery remains unclear in the literature. The purpose of this systematic review and meta-analysis is to evaluate the safety and efficacy of TXA compared to placebo treatment during or after AS surgery, by gathering data from randomized both controlled trials (RCTs) and non-RCTs.MethodsEnglish and Chinese electronic databases including PubMed, Web of Science, Embase, Cochrane, CNKI, and Wan Fang database were searched to identify the relevant literature up until August 2022. The primary outcomes were intraoperative blood loss and total blood loss. The secondary outcomes included the need for transfusion, postoperative hemoglobin (Hb) level, and change in Hb level. Stata 17 was used for data analysis and the risk of bias was assessed. We followed the PRISMA checklist to ensure the quality of this article.ResultsTwelve studies (795 participants) were included in the meta-analysis for intraoperative blood loss during surgery. The results suggest that TXA can reduce the intraoperative blood loss of the patients (MD = -306.40ml, 95%CI = -404.04ml to -208.77ml, p < 0.001). Six studies (2027 patients) were included in the meta-analysis for total blood loss. The pooled result shows that the total blood loss of the TXA group was significantly lower than that of the control group (MD = -779.24ml, 95% CI = -1157.10ml to -410.39ml, p < 0.001). Five studies (419 patients) were included in the meta-analysis for postoperative Hb level and shows a non-significant outcome (MD = 5.09 g/l, 95%CI = 2.92 g/l to 7.25 g/l, p = 0.611). Three studies (268 patients) were included in the meta-analysis for the postoperative Hb level. There is a non-significant decrease in the TXA group (MD = -0.23 g/l, 95%CI = -0.48 g/l to 0.01 g/l, p = 0.319). Eight studies (670 patients) reported data on the need for transfusion after surgery. The overall relative risks (RR) showed a significant difference between the TXA and control group, with a lower risk of transfusion in the TXA group (RR = 0.547, 95%CI = 0.308 to 0.972, p = 0.04).ConclusionsThe meta-analysis of the data reveals that TXA usage is associated with a significant reduction in intraoperative and total blood loss, a lower risk of transfusion, and a non-significant change in postoperative Hb levels in AS surgery However, it should be noted that the surgical operation situations varied across different studies. Therefore, further research is required to investigate the effects of TXA on specific subgroups of gender, operation time, and blood transfusion indicators. Overall, our study provides valuable evidence for the clinical management of AS surgery and may inform the development of practice guidelines and protocols for the use of TXA in this setting.

Incidence and predictors of hypophosphataemia after ferric carboxymaltose use-A 3-year experience from a single institution in Singapore.

Ferric carboxymaltose (FCM) administration helps reduce transfusion requirements in the perioperative situation, which improves patient outcomes and reduces healthcare costs. However, there is increasing evidence of hypophosphataemia after FCM use. We aim to determine the incidence of hypophosphataemia after FCM administration and elucidate potential biochemical factors associated with the development of subsequent hypophosphataemia. A retrospective review of anonymised data of all FCM administrations in a single institution was conducted from August 2018 to August 2021. Each unique FCM dose administered was examined to assess its effect on Hb and serum phosphate levels within the subsequent 28 days from each FCM administration. Phosphate levels were repeatedly measured within the 28-day interval and the lowest phosphate level within that period was determined. Patients' serum phosphate levels within 28 days of FCM administration were compared against normal serum phosphate levels within 2 weeks before FCM administration. The odds ratios of various pre-FCM serum markers were calculated to elucidate potential biochemical predictors of post-FCM hypophosphataemia. In 3 years, a total of 1296 doses of FCM were administered to 1069 patients. The mean improvement in Hb was 2.45 g/dL (SD = 1.94) within 28 days of FCM administration, with the mean time taken to peak Hb levels being 6.3 days (SD = 8.63), which is earlier than expected, but was observed in this study and hence reported. The incidence of hypophosphataemia <0.8 mmol/L was 22.7% (n = 186), and <0.4 mmol/L was 1.6% (n = 9). This figure is lower than the numbers reported in previously published meta-analyses given that routine checks of serum phosphate levels were not conducted initially and hence could possibly be higher. The odds of developing hypophosphataemia (<0.8 mmol/L) were 27.7 (CI: 17.3-44.2, p < 0.0001) if baseline serum phosphate was less than 1 mmol/L. The odds of developing hypophosphataemia (<0.8 mmol/L) were 1.3 (CI: 1.08-1.59, p < 0.01) if the change in Hb levels observed after FCM administration were more than 4 g/dL. Hypophosphataemia after FCM administration is significant and FCM should be used by clinicians with caution.

#4927 DARBEPOETIN ALFA ONCE IN 4 WEEKS CORRECTS ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE NOT ON DIALYSIS

Abstract Background and Aims In anemia management in patients with CKD not on dialysis (CKD ND), darbepoetin alfa (DA), which has shorter half-life but lower cost than continuous erythropoietin receptor activator (C.E.R.A.), is preferred in actual clinical practice in Korea. The current study evaluated the efficacy and safety of DA every 4 weeks (Q4W) compared to C.E.R.A. Q4W administration for in erythropoiesis-stimulating agent (ESA)-naïve patients with CKD ND. Method In this randomized, prospective, noninferiority study, 40 ESA-naïve patients with CKD ND were randomized 1:1 to receive either DA or C.E.R.A. Q4W during a 12-week correction period and 24-week efficacy evaluation period (EEP). Two primary efficacy end points were analysed: 1) the mean difference in the changes in haemoglobin (Hb) levels between baseline and EEP and 2) the Hb response rates defined as the proportion of patients who reached the target Hb level range (10-11 g/dL) during correction period. The non-inferiority margin is pre-defined as: 1) The lower limit of the 95% confidence interval (CI) is &amp;gt;-0.75 g/dL for the mean difference in the changes in Hb levels and 2) &amp;gt;60% for Hb response rates. Safety profiles including changes in blood pressure (BP), laboratory safety parameters, and frequency of all adverse events (AEs) were monitored and analysed during study period. Results The mean difference in the changes in Hb levels between the two groups was [0.375 g/dL; 95% confidence interval (CI), -0.446 to 1.196)] and [-0.070 g/dL; 95% CI, -0.730 to -0.590] in the intent-to-treat (ITT) and per-protocol (PP) population, respectively (Fig. 1). The Hb response rates in correction period were comparable between DA and C.E.R.A. group; [100%; 95% CI, 81.4 to 100] versus [94.1%; 95% CI, 71.3 to 99.8)] and [100%; 95% CI, 79.4 to 100] versus [100%; 95% CI: 88.2 to 100)] in ITT and PP population, respectively (Fig. 2). The mean estimated glomerular filtration rate, systolic and diastolic BP, sodium, and potassium level over time were not different during total study period between two groups (P = 0.264, 0.999, 0.823, 0.941, and 0.978). All of the AEs in each group were reported to be mild to moderate in intensity. Peripheral edema, neck pain, herpes zoster, and dyspnea occurred in DA group (20%) and urinary tract infection, dyspnea, and femur neck fracture occurred in C.E.R.A. group (15%). There were no serious AEs which led to discontinuation of the treatment. All AEs were mild to moderate in severity, and they are probably not associated with the study drugs and were successfully cured. The reasons for discontinuation of the drugs were starting HD or follow-up loss, but not due to the administered study drugs. No subjects received RBC transfusion or iron replacement therapy in both groups. There was no death during the study period. Conclusion These study results suggest that DA Q4W has non-inferiority in anemia correction efficacy and similar safety profiles compared to C.E.R.A. Q4W in ESA-naïve patients with CKD ND.

#3712 INTRAVASCULAR VOLUMES AND THE INFLUENCE ON ANAEMIA IN PATIENTS UNDERGOING MAINTENANCE HAEMODIALYSIS

Abstract Background and Aims Fluid overload is a major challenge in haemodialysis (HD) patients and might cause hypervolaemia. We speculated that HD patients reaching dry weight could have undetected hypervolaemia and low haemoglobin concentration (Hb) due to haemodilution. Method The study included HD patients (n = 22) and matched healthy controls (n = 22). Blood volume, plasma volume, red blood cell volume, and total haemoglobin mass (Hb mass) were determined using a carbon monoxide (CO)-rebreathing method in HD patients reaching dry weight and controls. Blood volume measurements were also obtained by a dual-isotope labelling technique in a subgroup for validation purposes. Results Blood volume was higher in 16 out of the 22 HD patients compared to controls. In the HD group, the median blood volume was 89.3 mL/kg (interquartile range (IQR) 76.7–95.4 mL/kg) and was higher than in the control group (79.9 mL/kg (IQR 70.4–88.0 mL/kg); P &amp;lt; 0.037) (Table 1). The median plasma volume was 54.7 mL/kg (IQR 47.1–61.0 mL/kg) and 44.0 mL/kg (IQR 38.7–49.5 mL/kg) in the HD and control groups, respectively (P &amp;lt; 0.001). Hb was lower in HD patients (P&amp;lt;0.001), whereas no difference in total Hb mass was observed between groups (P = 0.11). Changes in Hb levels during and after dialysis were observed in the HD group and is shown in Fig. 1. A correlation was found between blood volume measured by the CO-rebreathing test and the dual-isotope labelling technique in the control group (r = 0.83, P = 0.015), but not the HD group (r = 0.25, P = 0.60). Conclusion The HD group had increased blood volume at dry weight due to high plasma volume, indicating a hypervolaemic state. The total Hb mass was similar between HD patients and controls, unlike Hb, which emphasizes that Hb is an inaccurate marker of anaemia among HD patients.

Utility of Continuous Pulse Co-Oximetry for Hemoglobin Monitoring in Pediatric Patients with Solid Organ Injuries at Level 1 Trauma Centers: A Pilot Study.

Hemorrhage is a major cause of preventable death in injured children. Monitoring after admission often requires multiple blood draws, which have been shown to be stressful in pediatric patients. The Rainbow-7 device is a continuous pulse co-oximeter that measures multiple wavelengths of light, permitting continuous estimation of the total hemoglobin level. The purpose of this study was to evaluate the utility of the noninvasive hemoglobin measurement for monitoring pediatric trauma patients admitted with solid organ injury (SOI). This is a prospective, dual-center, observational trial for patients under age 18 admitted to a Level I pediatric trauma center. Following admission, blood was routinely measured as per current SOI protocols. Noninvasive hemoglobin monitoring was initiated after admission. Time-synced data for hemoglobin levels was compared to that taken using blood draws. Data was evaluated using bivariate correlation, linear regression, and Bland-Altman analysis. Over a 1-year period, 39 patients were enrolled. Mean age was 11 (±3.8) years. Forty-six percent (n = 18) of patients were male. Mean ISS was 19 ± 13 The average change in hemoglobin levels between laboratory measurements was -0.34 ± 0.95 g/dL and the average change in noninvasive hemoglobin was -0.12 ± 1.0 g/dL/measurement. Noninvasive hemoglobin values were significantly correlated with laboratory measurements (p < 0.001). Trends in laboratory hemoglobin measurements were highly correlated with changes in noninvasive levels (p < 0.001). Bland-Altman analysis demonstrated similar deviation from the mean throughout the range of hemoglobin values, but the differences between measurements was increased by anemia, African American race, and elevated SIPA score and ISS. Noninvasive hemoglobin values demonstrated correlation with measured hemoglobin concentration as isolated measurements and trends, although results were affected by skin pigmentation, shock, and injury severity. Given the rapid availability of results and the lack of requirement of venipuncture, noninvasive hemoglobin monitoring may be a valuable adjunct for pediatric solid organ injury protocols. Further study is required to determine its role in management. III, Study Type: Diagnostic Test.