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Response to DDAVP In mild Hemophilia A patients, in Search for dEterminants

The aim of this project is to investigate the association between clinical and genetic factors and DDAVP response in MHA patients and to determine their relative contributions to the DDAVP response.

A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 (N8-GP) when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia A

Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…

Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of personalized prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemophilia A

Primary Objective• To compare the annualised total bleeding rate of individually tailored prophylaxis with the historical bleeding rate observed in patients having received on-demand treatment with Human-cl rhFVIII from study GENA-01Secondary…

Efficacy and Safety of NNC 0129-0000-1003 during Surgical Procedures in Patients with Haemophilia A

Primary Objective: * To evaluate the haemostatic effect of N8-GP during surgical procedures in patients with haemophilia A. Secondary Objectives * To evaluate the general safety including immunogenicity of N8-GP when used for prevention and…

7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties
of oral rivaroxaban in children from birth to less than 6 months with arterial or venous
thrombosis

The primary objective is:- to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxabanThe secondary objectives are:- to assess the incidence of major bleeding and clinically relevant non-major bleeding- to…

An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A

An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A.…

30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children with various manifestations of venous thrombosis.

-Assess the incidence of major bleeding and clinically relevant non-major bleeding -Assess the incidence of recurrent venous thromboembolism -Characterize the pharmacokinetic/ pharmacodynamic profile of a 30-day treatment with oral rivaroxaban

Monitoring of residual heparinisation after cardiac surgery with thromboelastography (TEG) and postoperative bloodloss

1. Determine correlation between residual heparinisation and post-operative blood loss after elective cardiac surgery2. Determine the extent to which TEG delta R can predict post-operative blood loss3. Determine the extent to which ACT measurement…

Perioperative Management of Patients who are Receiving a Novel Oral Anticoagulant (Dabigatran, Rivaroxaban or Apixaban) and Require an Elective Surgery or Medical Procedure: A Prospective Cohort Study (PAUSE)*

1.1 Overall Aim: To establish a safe, standardized protocol for the perioperative management of patients with atrial fibrillation (AF) who are receiving a novel oral anticoagulant (NOAC) drug, either dabigatran, rivaroxaban or apixaban, and require…

Mont Blanc 2: Where Red And White Meet Again

We aim to investiga the effect of hypoxia on blood coagulation and the blood cells, particularly on blood cell activation, microparticle release and expression of anionic phospholipids on the cell membrane. We also want to investigate whether the…

A Phase II/III, multicenter, partially randomized, open label trial investigating safety and efficacy of on-demand and prophylactic treatment with BAY 94-9027 in Severe Hemophilia A

PART A: To assess the efficacy of BAY 94-9027 in prevention and treatment of bleeding at different infusion schedules.PART B: To assess the safety and efficacy of BAY 94-9027 in the prevention of bleeding during major surgical procedures.

A Phase 3 clinical study to determine the pharmacokinetics, safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding episodes in subjects diagnosed with von Willebrand disease

Primary objective:• Assess the pharmacokinetics (PK) of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary VWDSecundary objectives:• Compare the…

An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant, Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B.

Primary: The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B.Secondary: The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of…

Evaluating point-of-care prothrombin time measurements for cardiac surgery

Ex vivo study: What is the relation between increasing heparin concentrations and different protamine:heparin-ratio*s with POC-PT values in blood drawn from healthy volunteers?Clinical study in cardiac surgery: Does the POC-PT device correspond with…

intra-individual platelet activation, as meased by PFA-200, at different time lapses after aspirin intake

To eveluate the effect of amount of time past after last aspirin intake on platelet activability

Follow up ALIFE study

The objective of this study is to collect blood samples of women who participated in the ALIFE trial, to test for several DNA-variations as well as anti β2 glycoprotein antibodies, but also to perform overall coagulation assays, such as clot lysis…

Effects of DDAVP (1-deamino-8-D arginine vasopressin) infusion on parameters of hemostasis in patients with liver cirrhosis

This study aims to collect biochemical evidence for the pro-hemostatic capacity of DDAVP in patients with cirrhosis, in order to proceed towards a more rational clinical use of this drug.

Acute coagulopathy and inflammation of trauma

The Activation of Coagulation and Inflammation in Trauma (ACIT) study is designed to identify the clinically significant mechanisms and pathways by which inflammation and coagulation are activated immediately following major trauma, and how these…

Bloodloss study after Aortic valve replacement
Impact of Mecc perfusion vs conventional ECCperfusion

Peri-operative Bloodloss after Aortic valve replacement

Effect of anticoagulants or procoagulants on thrombin generation in PPP, PRP and whole blood

The main objective is to determine the effect of different anticoagulant and procoagulant agents on thrombin generation in whole blood and compare it to the effect on thrombin generation in PPP and PRP at different tissue factor concentrations. In…