Coagulation Profile Research Articles

Menstrual challenges in puberty: Investigating menorrhagia in adolescent girls

Menorrhagia, defined as excessive or prolonged menstrual bleeding, poses a significant challenge during this developmental stage, potentially impacting the health and well-being of adolescent girls. Despite its prevalence, comprehensive studies on menorrhagia in this specific demographic are scarce. This study aims to address this gap by investigating the underlying causes and treatment outcomes of puberty menorrhagia.A six-month observational study involving 50 adolescent girls presenting with menorrhagia was conducted at the Department of Obstetrics and Gynecology in a tertiary care center. The study utilized consecutive enumerative sampling and included a thorough investigation of participants, collecting data on demographic profiles, symptom severity, anemia levels, diagnoses, therapy requirements, and responses to conservative management. Baseline investigations encompassed a range of tests, including pregnancy exclusion, complete blood count, coagulation profile, and hormonal assays.The study cohort of 50 participants revealed varying characteristics: 24% were under 14 years, 34% were between 14-16 years, and 42% were aged 17-19 years. BMI distribution showed 14% below 18.5, 76% between 18.5 and 25, and 10% exceeding 25. Symptom duration included 20% reporting less than 6 months, 34% between 6-12 months, and 46% over 12 months. Etiology analysis indicated 60% with ovulatory dysfunction. Hemoglobin level analysis illustrated the prevalence and severity of anemia. Diverse treatments, including hormonal and non-hormonal interventions, were administered.This study provides insights into the causes of puberty menorrhagia, emphasizing the need for a holistic treatment. Future research should delve deeper into identified associations and clinical variants to enhance our understanding and guide effective interventions. Management should be directed to the cause.

Challenges in diagnosing disseminated congenital tuberculosis in a neonate: outcome and maternal treatment opportunity

In India, congenital tuberculosis (TB) accounts for 1%–3% of the TB burden. We present the case of a term neonate admitted with respiratory distress, hepatosplenomegaly and abnormal coagulation profiles. The neonate’s condition rapidly deteriorated, progressing to respiratory failure within 72 hours of admission. Tuberculosis-specific tests (TB PCR and culture) in the neonate confirmed the diagnosis of disseminated congenital TB. However, the results arrived after the neonate succumbed to multiorgan failure following a brief hospital stay. Maternal chest imaging after these results revealed miliary TB and she was started on anti-TB treatment. Despite the concerning signs, congenital TB was not initially suspected due to the absence of relevant maternal history and the overlapping features with other infections. As a result, the initial differentials considered were bacterial sepsis, perinatal viral infections and immunodeficiency. This case underscores the need for earlier suspicion of congenital TB, particularly in TB-endemic areas, to avoid adverse outcomes.

Altered coagulation profile of patients with high-grade glioma: clinical study with control group.

Altered coagulation profile of patients with high-grade glioma: clinical study with control group.

Evaluation of some haematological and coagulation profiles of occupationally heat stress individuals of bakery industries in Kano, Nigeria

Bakers are exposed to heat stress in their work places, which can result in a variety of outcomes ranging from mild heat cramps to heat stroke. There is paucity of published data on the wallop of heat stress on haematologic and haemostatic parameters of individuals occupationally exposed to heat stress from bakery industries. This study attempted to evaluates some haematological and coagulation parameters of bakery workers who are occupationally exposed to heat stress in the baking industries. One hundred (100) individuals who consented to participate among which are: 70 bakers and 30 non-bakers were enrolled into the study. Blood samples were obtained using aseptic venepuncture and assessed for haematologic and haemostatic parameters by Haematology-analyser for full blood count parameters and manual standard coagulation method for Prothrombin time (PT) and activated partial thromboplastin time (aPTT) respectively. The data obtained was analyzed using IBM SPSS version 23. The results are presented as mean and standard deviation and p-value was set at ≤0.05as statistically significant. Platelets, red and white blood cells counts and their indices were counted along with some coagulation parameters (PT and aPTT). A statistically significant increase (p≤0.05) in platelets counts were observed in bakers compared with controls. Similarly, some coagulation parameters were found to be reduced and was statistically significant (p≤0.05) in bakers compared with non bakers as controls. The findings of the study showed insignificant changes in haematologic parameters coupled with altered coagulation parameters. This may be suggestive that individuals occupationally exposed to heat stress are prone to hypercoagulable state and its attending consequences.

Prevalence of High Activated Partial Thromboplastin Time (aPTT) among Patients with Liver Cirrhosis Department of Medicine at Saidu Group of Teaching Hospital, Swat

Introduction: Chronic liver disease or liver cirrhosis is a disease condition in which fibrosis and the creasing of the liver are not functioning correctly. The severity of cirrhosis depends upon the extent of liver failure. Advanced stages of liver failure that create an abnormal coagulation profile have increased the tendency towards bleeding and have consequently increased the hospitalization rates and mortality among cirrhotic patients. Activated partial thromboplastin time is a test that measures activity of Factors VII, IX, XI, and XII. An increased aPTT is due to decreased synthesis of measuring clotting factors in the sample indirectly decreases synthesis from the liver. Department of Medicine, Saidu Group of Teaching Hospital Swat Duration of study: From 13 August 2020 to 14 Feb 2021. Total 195 cases of cirrhosis are consecutively selected from OPD and activated partial thromboplastin time (aPTT). Results: The mean age of sample was 45.2 + 7.3 years. 68.2% was male gender while 31.8% is female gender. The mean duration of the disease was 7.1 + 2.5 years. The results showed acute decompensation in 34.9% and 30.8% had hospitalization history due to decompensation. Cardiac drug use history was present in 34.9%. The results further showed that 45.1% patients were diagnosed with prolonged aPTT. Conclusion: Prolongation of aPTT is a frequent problem in our local cirrhotic population. Further studies are needed to develop an association of factors that lead to the prolongation of aPTT, its control, and its effect on morbidity and mortality of patients with cirrhosis. Keywords. Liver cirrhosis, coagulation disorders, activated partial thromboplastin time, acute decompensation

Brief communication: coagulation profiles of HIV positive patients on antiretroviral therapy (ART) at the Mampong Municipal Hospital, Ashanti-Region, Ghana: a case control study

This study aimed to ascertain how the current two ART regimens used in Ghana affected HIV patients’ coagulation profiles. A case-control study was conducted on 102 HIV positive patients at the Mampong Municipal Hospital. Coagulation parameters measured showed APTT was normal in majority of ART-experienced participants but prolonged in majority of ART-naïve participants. The mean platelet count was significantly higher in ART-experienced participants. No significant differences were found between the coagulation profiles of ART-experienced patients on two different drug regimens. In conclusion, current ART can enhance the coagulation profiles in HIV-infected patients, by improving platelet count and APTT.

Coagulation Profile and Clot Stiffness Analysis from COVID-19-Positive Patients Using a Contactless Viscoelasticity Testing Technology

Coagulation Profile and Clot Stiffness Analysis from COVID-19-Positive Patients Using a Contactless Viscoelasticity Testing Technology

A Rare Case of Acute Promyelocytic Leukemia with Concomitant PML-RARA Fusion and TP53 Loss/ider(17)(q10)t(15;17) Showing Complete Clinical and Molecular response: A Case Report

Abstract Introduction/Objective To report a case with rare cytogenetic abnormality: a patient with newly diagnosed acute promyelocytic leukemia (APL) with cytogenetic findings of t(15;17)(q24;q21), trisomy 8 and ider(17)(q10)t(15;17)-TP53 loss. The presence of isochromosome 17q may indicate the possibility of an unfavorable outcome. However, the case showed complete clinical and molecular response. Methods/Case Report A case of a 53-year-old female with history of ITP post-splenectomy presented with persistent hematuria, easy bruising, and worsening fatigue. She had mild microcytic anemia, moderate thrombocytopenia, 3% promyelocytes, and 14% blasts on differential CBC count. With increased PT, PTT, LDH, Uric acid and decreased fibrinogen level, APL was clinically suspected. The patient was initiated on all-trans retinoic acid (ATRA), allopurinol, and IV fluids. Bone marrow (BM) biopsy confirmed the diagnosis with unusual cytogenetic findings. The patient underwent induction and consolidation therapies (4 weeks each) with ATRA plus Arsenic Trioxide (ATO) and followed- up with a series of marrow biopsies, cytogenetic and molecular studies. Results (if a Case Study enter NA) The patient demonstrated complete clinical, histological, and molecular response. She tolerated the treatment without major side effects, showing improvement in CBC counts, coagulation profile and tumor lysis labs. Initial BM exam revealed hypercellularity with infiltrating sheets of atypical hypergranular promyelocytes (~80%) and minimal residual left trilineage hematopoiesis. Flow cytometry revealed a CD34 negative, CD117 variable abnormal promyelocyte population (~67% of total events). FISH was positive for PML/RARA translocation (15; 17) and TP53 loss. Karyotype showed 46,XX,der(15)t(15;17)(q24;q21),ider(17)(q10)t(15;17)[12]/47,idem,+8[9]. By the end of treatment, BM biopsy was normocellular with trilineage hematopoiesis and no definitive evidence of acute leukemia or increase in blasts. The Karyotype was normal. Quantitative PCR for PML-RARA was negative, indicating complete molecular remission. Conclusion In this unique case of APL with unusual cytogenetic abnormalities the literature demonstrates controversial data. The patient achieved complete clinical and molecular remission following standard treatment. This may indicate the limited prognostic significance of these additional cytogenetic abnormalities in this case.

Evaluation of Red Blood Cell Biochemical Markers and Coagulation Profiles Following Cell Salvage in Cardiac Surgery: A Systematic Review and Meta-Analysis.

Background: Individuals undergoing cardiac surgery face an increased risk of bleeding, as well as alterations in biochemical and coagulation patterns. Therefore, assessing the effectiveness of systems such as Cell Salvage is necessary to prevent potential surgical complications. Objective: To evaluate the efficacy of Cell Salvage in relation to the biochemical parameters of the red blood series and coagulation, as well as the risk of hemorrhage. Methods: A systematic review, accompanied by a meta-analysis, was executed via an extensive literature exploration encompassing Medline, CINAHL, Scopus, Web of Science, and the Cochrane Library. The inclusion criteria comprised studies in English or Spanish, without year restrictions, conducted in adults and with a randomized controlled trial design. Results: Twenty-six studies were included in the systematic review, involving a total of 2850 patients (experimental group = 1415; control group = 1435). Cell Salvage did not demonstrate superior outcomes compared to allogeneic transfusions in the management of post-surgical hemorrhage, as well as in total blood loss, platelet count, fresh frozen plasma, and fibrinogen. However, Cell Salvage showed a greater effectiveness for hemoglobin (moderate evidence), hematocrit (low evidence), post intervention D-dimer (low evidence), and some coagulation-related parameters (low evidence) compared to allogeneic transfusions. Finally, better results were found in the control group for INR parameters. Conclusions: The use of the Cell Salvage system holds high potential to improve the postoperative levels of biochemical and coagulation parameters. However, the results do not provide definitive evidence regarding its effectiveness for hemorrhage control, platelet count, fresh frozen plasma, and fibrinogen. Therefore, it is recommended to increase the number of studies to assess the impact of the Cell Salvage system on improvements in the red blood cell count and patient coagulation patterns. In addition, protocols should be homogenized, and variables such as the sex of the participants should be taken into account.

Association Between Cerebral Microbleeds and Neurological Outcomes in Patients Who Underwent Extracorporeal Membrane Oxygenation.

Cerebral microbleeds (CMBs) are common and varied in patients receiving extracorporeal membrane oxygenation (ECMO). Here, the authors describe CMB findings in patients receiving ECMO and their association with clinical factors. A total of 138 patients receiving ECMO were enrolled and categorized as venovenous and venoarterial. Blood coagulation profiles during ECMO support and Glasgow Coma Scale (GCS) scores within 7 days were recorded. Patients with CMBs exhibited prolonged activated clotting time (P<0.001), decreased fibrinogen levels (P<0.001), reduced platelet counts (P<0.001), and extended prothrombin time (P<0.001). A significant correlation (P<0.05) was observed between the presence of CMBs and most coagulation parameters among all patients. Patients with venoarterial ECMO had significantly higher activated partial thromboplastin time, activated clotting time, and prothrombin time compared with those with venovenous ECMO (all P<0.05). Patients with a less severe CMB burden exhibited higher GCS scores and better neurological injury outcomes at both 7 and 90 days. CMB burden in all patients with ECMO was significantly correlated (P<0.05) with most blood coagulation profiles and neurological injury. CMB burdens after ECMO are common, varied, and associated with a variety of clinical conditions. These findings may guide ECMO management.

Experiences of Therapeutic Plasma Exchange in geriatric patients at a tertiary care hospital in western Maharashtra: An observational study

BackgroundGeriatric patients undergo Therapeutic Plasma Exchange (TPE) for variety of indications that poses its unique challenges and complications. We present our experience with TPE in geriatric patients in terms of diseases encountered and adverse events, if any, witnessed during the procedure. MethodsA prospective analysis of TPE procedures was done for a period of 01 year. Patients above 60 years of age with a range of 01–02 volume exchange per procedure were enrolled in the study. Baseline procedure investigations such as complete blood count, serum electrolytes, coagulation profile, and transfusion-transmitted infection screening were carried out before the TPE procedure. All TPE procedures were performed using a continuous-flow cell separator. All these patients were followed-up, and findings related to patients and procedures were documented. ResultsA total of 21 eligible enrolled patients underwent 85 procedures in the present study. Neurological disorders (80.9%, n = 17) were most common indication, with Guillain–Barre syndrome (42.8%, n = 9) being tthe most replaced by second common, followed by myasthenia gravis (23.8%, n = 5). Barring one, all other patients showed significant clinical response. The overall incidence of complications during the study was 80.9% (n = 17), among which majority were patient-related (94.11%, n = 16). However, only one procedure was terminated due to a machine error, and there were no procedure-related deaths. ConclusionThe current study showed that TPE in geriatric patients gives substantial results in terms of clinical improvement but is fraught with multiple complications. However, in trained and expert hands, these complications can be managed effectively.

Coagulation profiles and percentiles in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia: A step toward more accurate transfusion thresholds.

In the literature, there are no studies about the transfusion threshold for neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia (TH). In order to facilitate accurate interpretation of coagulation results in these neonates, we aimed to generate specific reference intervals in this specific population. This retrospective study included all HIE neonates admitted from 2014 to 2022 to undergo TH. All infants during TH underwent blood exams, including the coagulation profile. Our primary outcome was to assess the estimates of the 3rd, 10th, 25th, 50th, 75th, 90th, and 97th percentiles for each parameter on admission (before transfusion). By the receiver operating characteristic (ROC) analysis, the area under the ROC curve (AUC) and the best cut-off point were used to evaluate the ability of the prothrombin time expressed as international normalized ratio (PT-INR) to predict the risk of any bleeding. A total of 143 infants were included in this study. On admission, the median fibrinogen value was 205mg/dL, prothrombin time 18.6seconds, PT-INR 1.50, activated partial thromboplastin time 38.3seconds, thrombin time 18.6seconds, antithrombin 57.0%. The optimal cut-off of PT-INR in predicting the risk of any bleeding was greater than 1.84 (AUC.623, p=.024). For the first time, we proposed the percentiles of coagulation parameters in our cohort of neonates with HIE. Furthermore, we found that a PT-INR greater than 1.84 can significantly predict the risk of any bleeding. Further studies are needed to determine if a restrictive versus a liberal transfusion approach can be equally safer for these high-risk infants.

The TEG 6s Global Hemostasis System is Useful for Coagulation Management in Simultaneous Pancreas and Kidney Transplantation: The First Two Cases

Introduction: Hypercoagulability-related graft thrombosis is the leading cause of graft failure after simultaneous pancreas-kidney transplantation (SPK). Addressing this issue is crucial to improve the outcomes of SPK recipients. Thromboelastography (TEG) has been used to assess the coagulation profiles of SPK recipients. Recently, a new-generation TEG device, the TEG 6s Global Hemostasis System, was introduced. This device offers advantages over TEG 5000, including less frequent calibration requirements, ease of use, and reduced sensitivity to movement. We hypothesized that TEG 6s would enhance coagulation management in SPK. Methods: We report two cases of Asian female SPK recipients in whom TEG 6s was used to assess coagulation status at six preset times during and after surgery. Results: Preoperatively, both patients exhibited hypercoagulability on TEG 6s. Postoperative intravenous heparin was administered, and the dose was titrated based on the TEG 6s results. Vascular thrombosis was not observed in either patient. Detailed TEG 6s and standard laboratory test results are reported. This pilot study demonstrates that TEG 6s monitoring can effectively assess coagulation status in SPK recipients, aiding in optimal coagulation management and reducing the risk of thrombotic complications leading to graft loss. The TEG 6s facilitated real-time and accurate coagulation assessment, allowing for tailored anticoagulant therapy. Conclusions: This is the first observational study to use TEG 6s in SPK recipients, indicating its potential benefits in improving patient outcomes. Further studies with larger sample sizes are warranted to validate these findings and establish comprehensive guidelines for using TEG 6s in SPK procedures.

Assessments of coagulation profile among good glycemic control and poor glycemic control type 2 diabetic patient attending at Wolkite University specialized hospital, Central Ethiopia: a comparative study

IntroductionDiabetes Mellitus (DM) is a worldwide health issue that is defined by elevated blood glucose levels and impaired metabolism of fat, carbohydrates, and proteins. Atherosthrombotic events are very likely to occur in patients with diabetes mellitus. This results in the development of both microvascular and macrovascular complications.ObjectiveTo compare the coagulation profile parameters between patients with good glycemic control and poor glycemic control and to evaluate the association of coagulation profile and glycemic control in type 2 DM patients.Materials and methodsThis study was conducted in Wolkite university specialized hospital on 90 type 2 Diabetics patients among which 45 were with good glycemic control and 45 were with poor glycemic control. Seven ml blood samples were collected from each study participant and analyzed to assess coagulation profile including Platelet Count, activated Partial Thromboplastin Time (aPTT), and Prothrombin Time (PT). Using SPSS 21.0, an independent sample t-test was used for statistical analysis.ResultsAccording to the current study, when comparing Type 2 Diabetes with poor glycemic control to those with good glycemic control, there was an increase in PT and aPTT concentration (statistically significant, p < 0.05). The platelet counts of the two groups did not differ significantly.ConclusionPeople with Type 2 diabetes have altered coagulation profiles, which have demonstrated that hyperglycemia causes abnormalities in coagulation. Patients with Type 2 diabetes who have poor glycemic control are particularly vulnerable to atherothrombotic and hemorrhagic events. In order to prevent the onset of microvascular and macrovascular illness as soon as possible, physicians may find it helpful to evaluate the coagulation profile of diabetic patients.

IRON OVER LOAD AND ITS RELATION WITH HAEMOSTATIC PARAMETERS IN BETA-THALASSEMIA PATIENTS

Background: Patients with beta-thalassemia major have been observed to experience changes in their coagulation profile. These changes include an elongated prothrombin time and partial thromboplastin time as well as bring down levels of natural anticoagulants and coagulation factors. The mechanisms underlying the occurrence of thrombotic tendencies in some thalassemia patients remain unclear. This study aims to examine the alterations in the iron and coagulation profile among beta-thalassemia patients. Methods: After informed consent, 50 children having beta-thalassemia, and 50 healthy controls were included in this study. Blood samples were collected and serum ferritin, haematological and haemostatic parameters were measured. Data was analysed on SPSS-24. Results: The laboratory assessment revealed 43.5% of the patients had thrombocytopenia, 54% had prolonged prothrombin time (PT), and 56% of the patients had prolonged activated partial thromboplastin time (aPTT). All estimated coagulation factors exhibited lower activity levels in comparison to the control group. Serum ferritin exhibited a positive relationship with PT and aPTT and a substantial negative relationship with total platelet count. Conclusion: High serum ferritin levels are associated to abnormal haemostatic parameters in thalassemia patients. Regular monitoring of serum ferritin levels is essential to ensure that thalassemia patients receive appropriate treatment and support. Pak J Physiol 2024;20(3):71–3, DOI: https://doi.org/10.69656/pjp.v20i3.1742

Comparative analysis of COVID-19 pneumonia in pregnant versus matched non-pregnant women: radiologic, laboratory, and clinical perspectives.

This study aimed to assess the severity and outcomes of COVID-19 in pregnant women, focusing on laboratory and radiological discrepancies between pregnant women and matched nonpregnant women. In this retrospective cross-sectional analysis, we matched 107 nonpregnant women with 66 pregnant women in terms of age, comorbidities, and the interval between symptom onset and hospital admission. Demographic, clinical, laboratory, and radiological data were collected, and chest CT scans were evaluated using a severity scale ranging from 0 to 5. Logistic regression and adjusted Cox regression models were used to assess the impact of various factors on pregnancy status and mortality rates. Differences in several laboratory parameters, including the neutrophil-to-lymphocyte ratio, liver aminotransferases, alkaline phosphatase, urea, triglycerides, cholesterol, HbA1c, ferritin, coagulation profiles, and blood gases, were detected. Radiologic exams revealed that nonpregnant women had sharper opacities, whereas pregnant women presented with hazy opacities and signs of crypt-organizing pneumonia. A notable difference was also observed in the pulmonary artery diameter. The mortality rate among pregnant women was 4.62%, which was comparable to the 5.61% reported in nonpregnant patients. Compared with nonpregnant patients, pregnancy did not significantly affect the severity or mortality of COVID-19. Our study revealed discernible differences in specific laboratory and imaging markers between pregnant and nonpregnant COVID-19 patients.

Comparative Study of Coagulation Profile and Haematological Parameters in Pregnancy-Induced Hypertension (PIH).

Background Pregnancy-induced hypertension (PIH) is a major cause of maternal and fetal morbidity and mortality. PIH, including gestational hypertension, pre-eclampsia, and eclampsia, often leads to significant alterations in coagulation profiles and haematological parameters, posing risks for thromboembolic and haemorrhagic complications. This study aimed to compare the coagulation and haematological parameters between women with PIH and normotensive pregnant women. Methods A cross-sectional observational study was conducted on 110 pregnant women, divided into two groups: 55 with PIH and 55 with normotensives. Coagulation markers such as prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalised ratio (INR), and platelet count were measured. Bleeding and clotting times were also evaluated. Data were statistically analysed using student's t-test and chi-square tests, with p ≤ 0.05 considered significant. Results Women with PIH exhibited significantly lower platelet counts, PT, aPTT, and INR values compared to the normotensive group (p < 0.0001). Thrombocytopenia and prolonged bleeding time were more common in the PIH group, suggesting an increased risk of both bleeding and clotting complications. Proteinuria was observed in 32 women (58.18%) in the PIH group, reflecting the severity of the disease. Additionally, the PIH group had markedly elevated blood pressure levels. Conclusion PIH is associated with significant coagulation and haematological abnormalities, including thrombocytopenia and a hypercoagulable state, which increase the risk of thromboembolic and hemorrhagic events. Routine monitoring of coagulation profiles and haematological parameters in PIH patients is essential for timely interventions and improving maternal and fetal outcomes.

THROMBOCYTOPENIA IN NEONATES: INCIDENCE, PRESENTATION, AND STUDY OF CORRELATED FACTORS AT A LAHORE TEACHING HOSPITAL

Background: Patients with thrombocytopenia have been observed to experience changes in their coagulation profile and severity of disease. This study aims to see the incidence, presentation, and correlating factors of thrombocytopenia in newborns. Methods: From Jan 2023 to Jan 2024, 200 newborns in the Paediatric and Pathology Departments of Chaudhry Muhammad Akram Teaching and Research Hospital participated in a cross-sectional study. Utilizing SPSS-23, overall data was analysed. Results: In this study 138 (69%) of the 200 newborns were female, and 62 (31%), were male. Seventy-six (38%) neonates had thrombocytopenia, whereas 124 (62%), neonates had normal platelet counts. Of the 76 newborns, 42 (21%) had mild thrombocytopenia, 25 (12.5%) had moderate thrombocytopenia, and 9 (4.5%) had severe thrombocytopenia. Thirty-five percent early-onset neonatal thrombocytopenia (EOT) had early onset thrombocytopenia, while 46 (23%) had thrombocytopenia in the late onset (LOT) phase. There was a strong correlation discovered between thrombocytopenia and anaemia, jaundice asphyxia, low birth weight, preterm and full-term neonatal birth, and neonatal jaundice. The correlation of bleeding in neonates with thrombocytopenia was significant (p&gt;0.05). Conclusion: Moderate to severe thrombocytopenia in newborns often follows mild thrombocytopenia. Thrombocytopenia is highly correlated with bleeding, preterm birth, full-term birth (extensive monitoring during childbirth), anaemia, hypoxia, and sepsis. In sick newborns, severe thrombocytopenia is considered as a prognostic marker. Pak J Physiol 2024;20(3):37–9, DOI: https://doi.org/10.69656/pjp.v20i3.1703

Pre‑operative mean platelet volume is associated with overall survival in patients with IDH‑wildtype glioblastoma undergoing maximal safe resection.

Glioblastoma (GBM) is the most common, fast-growing, and aggressive malignant primary CNS tumor, with a survival time of ~15 months despite the use of surgery and adjuvant treatments. In recent years, there has been a growing interest in exploring the potential contribution of hemostasis and platelet activation in GBM biology. The present study assessed the association between the pre-operative coagulation profile [as indicated by prothrombin time (PT) ratio and activated partial thromboplastin time (aPTT) ratio], overall platelets (PLT) count and the mean platelet volume (MPV) with tumoral characteristics and overall survival in patients with isocitrate dehydrogenase-wildtype (IDH-wt) GBM.

A multi-center, double-blind, placebo-controlled, randomized, parallel-group, non-inferiority study to compare the efficacy of goal-directed tranexamic acid administration based on viscoelastic test versus preemptive tranexamic acid administration on postoperative bleeding in cardiovascular surgery (GDT trial)

BackgroundTranexamic acid (TXA) effectively attenuates hyperfibrinolysis and preemptive administration has been employed to reduce bleeding and blood transfusions in various surgical settings. However, TXA administration could be associated with adverse effects, such as seizures and thromboembolic risks. While patients with fibrinolysis shutdown showed greater thromboembolic complications and mortality, TXA administration may aggravate the degree of shutdown in these patients.Selective TXA administration based on the results of rotational thromboelastometry (ROTEM) would be non-inferior to preemptive TXA administration in reducing postoperative bleeding and beneficial in reducing its risks in patients undergoing cardiovascular surgery.MethodsThis non-inferiority, randomized, double-blind, placebo-controlled, multicenter trial will be performed in 3 tertiary university hospitals from August 2023 to March 2025. Seven hundred sixty-four patients undergoing cardiovascular surgery will be randomly allocated to get TXA as a preemptive (Group-P) or goal-directed strategy (Group-GDT) in each institution (with a 1:1 allocation ratio). After anesthesia induction, TXA (10 mg/kg and 2 mg/kg/h) and a placebo are administered after anesthesia induction in Group-P and Group-GDT, respectively. ROTEM tests are performed immediately before weaning from CPB and at the considerable bleeding post-CPB period. After getting the test results, a placebo is administered in Group-P (regardless of the test results). In Group-GDT, placebo or TXA is administered according to the results: placebo is administered if the amplitude at 10 min (A10-EXTEM) is ≥ 40 mm and lysis within 60 min (LI60-EXTEM) of EXTEM assay is ≥ 85%, or TXA (20 mg/kg) is administered if A10-EXTEM is < 40 mm or LI60-EXTEM is < 85%. The primary outcome is inter-group comparisons of postoperative bleeding (for 24 h). The secondary measures include comparisons of perioperative blood transfusion, coagulation profiles, reoperation, thromboembolic complications, seizures, in-hospital mortality, fibrinolysis phenotypes, and hospital costs.DiscussionThe absence of inter-group differences in postoperative bleeding would support the selective strategy’s non-inferiority in reducing postoperative bleeding in these patients. The possible reduction in thromboembolic risks, seizures, and fibrinolysis shutdown in Group-GDT would support its superiority in reducing TXA-induced adverse events and the cost of their management.Trial registrationThis trial was registered at ClinicalTrials.gov with the registration number NCT05806346 on March 28, 2023.Trial status: recruiting.Issue date: 2023 March 28 (by Tae-Yop Kim, MD, PhD).The trial was registered in the clinical registration on March 28, 2023 (ClinicalTrials.gov, NCT05806346) and revised to the latest version of its protocol (version no. 8, August 26, 2024) approved by the institutional review boards (IRBs) of all 3 university hospitals (Konkuk University Medical Center, 2023–07-005–001, Asan Medical Center, 2023–0248, and Samsung Medical Center, SMC 2023–06-048–002). Its recruitment was started on August 1, 2023, and will be completed on December 31, 2024.Protocol amendment number: 08 (protocol version 08, August 26, 2024).Revision chronology:2023 March 28:Original.2023 April 10:Amendment No 01. The primary reason for the amendment is the modification of Arms (adding one arm for sub-group analyses) and Interventions, Outcome Measures, Study Design, Study Description, Study Status, Eligibility, and Study Identification.2023 May 03:Amendment No 02. The primary reason for the amendment is to modify the Outcome Measures and update the study status.2023 July 06:Amendment No 03. The primary reason for amendment is to update the chronological study status.2023 July 07:Amendment No 04. The primary reason for the amendment is the modification of study information (the treatment category was changed to diagnostic, and Phase 4 was changed to not applicable) and a chronological update on the study status.2023 September 12:Amendment No 06. The primary reason for the amendment is a chronological update in the study status and the inclusion of additional information regarding contacts/locations and oversight.2023 December 29:Amendment No 07. The primary reason for the amendment is to modify the outcome measures (including detailed information on outcome measures, addition of extra secondary measures, and chronological updates in study status).2024 August 26:Amendment No 08. The primary reason for the amendment is to add detailed descriptions regarding data handling and the names and roles of the participating institutions and to update the chronological process of the trial.