Use of NovoSeven® in Active Variceal Bleeding
Acquired Bleeding DisorderCirrhosisThis trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.
Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With...
Congenital Bleeding DisorderHaemophilia AThis trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.
Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized...
TraumaBleeding Disorder2 moreThis is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
Severe SepsisCoagulopathyThe purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass...
Cardiopulmonary BypassPlatelet Disorder2 morePatients admitted for coronary artery bypass surgery taking antiplatelet medicine have an increased risk for bleeding. Present study aims to compare the platelet function in two patient groups using different types of heart-lung machine methods. It is assumed that one of the methods is superior verified by sensitive methods of testing platelet function.
Viscoelastic Tests-Guided Therapy In Liver Transplantation
Liver Transplant; ComplicationsBleeding1 moreBACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation. METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.
Anticoagulant Clinics and Vitamin K Antagonists
Blood Coagulation DisordersBackground: Whether the management of vitamin K antagonists (VKA) therapy by general practitioners with the collaboration of anticoagulation clinics (ACC) provides better clinical outcomes than that accomplished by general practitioners alone (usual care [UC] management) is not clear. Objectives: To compare ACC-based shared-care management with UC management of VKA therapy with respect to clinical events. Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at least three months. The primary study outcome is a composite of confirmed symptomatic thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All outcomes are reviewed by a central, independent adjudication committee.
Dose Response to Recombinant Factor VIIa When Administered for Bleed
Congenital Bleeding DisorderHealthyThis trial is conducted in the United States of America (USA). The purpose of this trial is to investigate the dose response to recombinant factor VIIa in healthy volunteers when administered for bleed.
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy...
Acquired Bleeding DisorderAcquired Haemophilia6 moreThis trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
Establishment of Risk Factors Model of Drug-induced Coagulation Disorder Caused by Cefoperazone...
Risk FactorsThe incidence rate of drug-induced blood diseases accounts for about 10% of all drug-induced diseases, most of which are serious at the time of onset, and the mortality rate can be as high as 32.5%. In this study, cefoperazone sulbactam sodium, which is commonly used in clinic, was selected as the target drug, and the epidemiological characteristics of drug-induced coagulation dysfunction and the construction of risk factor models were studied by single factor and multiple factor Logistic regression analysis.