Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With...
Congenital Bleeding DisorderHaemophilia BThis trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.
Gene Therapy Study in Severe Hemophilia A Patients With Antibodies Against AAV5
Hemophilia AGene Therapy2 moreThis study is being conducted by BioMarin Pharmaceutical Inc. as an open label, single dose study to determine the safety of valoctocogene roxaparvovec (an Adenovirus-Associated Virus (AAV) based gene therapy vector) in severe Hemophilia A patients with pre-existing antibodies against AAV5.
The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation
Coagulation DisorderBloodThe purpose of this study is to assess a novel rotational thromboelastometry (ROTEM®) interpretation software to determine whether its use improves the accuracy of clinician interpretation.
Validation of Point-of-care Thromboelastography (TEG 6s) in Pediatric Patients
CoagulopathyThe goal of this observational study is to learn about the performance of the TEG6s in normal pediatric patients. The main questions it aims to answer are: What are the normal TEG 6S lab results in normal pediatric patients and how do they compare to existing published reference ranges. Participants and their guardians will be asked to submit a small amount of blood at the beginning of an elective operation for analysis in the TEG 6s machine.
Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
Heart DiseasesVascular Diseases4 moreThe present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery. The secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.
The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section
HyperfibrinolysisCesarean Section Complications2 moreThis study aims to find out if there are common major changes in coagulation immediately after delivery of the newborn during Cesarean (C) -section and vaginal birth.
Caudal Analgesia & Anticoagulated Patient
Lumbar Pain SyndromeAnticoagulants and Bleeding DisordersCaudal analgesia is an effective intervention for lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients. Quantitative analysis of prospective clinical data. Evaluation of caudal analgesia efficacy and safety in anticoagulated chronic pain patients. Analysis of outcome, and complications.
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Hematologic DisorderBleeding Disorder7 moreIn parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US.
The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
Patients Undergoing Routine Health CareHeart Diseases6 moreThe purpose of this study is to collect DNA samples from patients undergoing routine care at the University of Chicago. These samples will be tested for differences in genes that may suggest greater risk of side effects or chance of increased benefit from certain medications. The results will be made available to the patient's treating physician and the researchers will track whether or not this information is used in routine health care.
Hemostatic Variables In Snakebite Study
Snake BitesCoagulopathy1 moreBackground Novelty The global assays of coagulation, namely the viscoelastometric tests and clot waveform has never been studied in detail before in snakebite victims. The pathophysiology of VICC including specific factor deficiencies and serial trend in blood cell indices amongst various hematotoxic snakebite in the region is not known. No Indian study to date has systematically examined the changes in early laboratory tests results in envenomed and non envenomed snakebite victims.