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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…

Prothrombin complex concentrate in the reduction of blood loss during orthotopic liver transplantation.

To investigate in a randomized controlled trial, whether giving Cofact pre-operatively can reduce the bloodloss and transfusion requirements during orthotopic liver transplantation. Also we investigate the safety of Cofact in this patient population…

Comparison of a single dose fibrinogen with placebo and the number of blood transfusions after ascending aorta surgery (FIBTEG study)

The purpose of this study is to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions,…

Oral complications in patients treated with hematopoietic stem cell transplantation

Main study objectives:* To Identify the incidence, severity and temporal relationships of subjective and objective oral complications related to type of conditioning regimen in HSCT recipients* To determine which oral complications can predict…

A Phase 3b Clinical Study To Assess Whether Regular Administration Of Advate In The Absence Of Immunological Danger Signals Reduces The Incidence Rate Of Inhibitors In Previously Untreated Patients With Hemophilia A

Primary objective:Determine the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A during the first 50 exposure days (EDs) to starting with a once weekly prophylactic regimen together with the minimization…

Effect of incentive spirometry in prevention of acute chest syndrome during painful crisis in adult sickle cell patients

To evaluate the efficacy of incentive spirometry on the incidence of ACS in adult sickle cell patients admitted with a vaso-occlusive painful crisis.

Individually tailored elastic compression therapy after deep venous thrombosis in relation to the incidence of post thrombotic syndrome, a randomized multicenter trial

To assess the costs and effects of tailoring the duration of elastic compression stocking (ECS) therapy after deep vein thrombosis (DVT) to individual patients needs.

Transfusion of fresh frozen plasma in non bleeding ICU patients

With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgoup of ICU patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs…

Pilot feasibility study of Ferinject® in patients with esophageal cancer

The objective of this pilot study is to investigate wether:- Increased Hb levels prior to the operation can prevent blood transfusions preoperative, blood transfusions have a negative effect on the survival of cancer patients- Treatment with…

A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC-0156-0000-0009 when used for Treatment and Prophylaxis of Bleeding Episodes in Patients with Haemophilia B

Primary Objective: To evaluate the immunogenicity of N9-GP.Key Secondary Objectives: * To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of N9-GP.* To evaluate clinical efficacy of N9-GP in long term bleeding prophylaxis…

Preventing severe infection after splenectomy

The aim of this study is to evaluate the current practice of anti-infectious strategies in patients with an absent or dysfunctional spleen.

Leiden's IVIg trial in Rhesus disease of the Neonate

AimTo determine whether the prophylactic use of IVIg reduces the need for ET in neonates with Rh-D hemolytic disease.

A randomised, double blind placebo controlled trial to (A) assess the optimal vitamin K dosage for supplementation, and (B) to access wether complications of anticoagulation treatment will diminish by suppletion of vitamin K.

VIKS-2A:To determine the optimal dosage of vitamin K for supplementation to obtain a stable anticoagulation effect.VIKS-2B:To determine whether supplementation with the found optimal dosage of vitamin K from study VIKS-2A will decrease the number of…

VON WILLEBRAND DISEASE PROPHYLAXIS NETWORK (vWD PN)
The VWD International Prophylaxis (VIP) Study

The objectives are to:A. Identify subjects with VWD who may benefit from prophylaxis by determining patterns of bleeding prior to evaluation for enrollmentB. Study the effect of prophylaxis on bleeding frequencyC. Establish optimal treatment…

Changes in Microvascular perfusion, Exercise Tolerance and Perioperative Hemostasis after Treatment with Intravenous Iron of Patients with Mild Anemia Undergoing Arterial Vascular Surgery

To measure the effect of intravenous ferric carboxymaltose treatment on exercise tolerance, microvascular perfusion and perioperative hemostasis in patients with mild iron deficiency anemia undergoing arterial vascular surgery.

Safety and Efficacy of NNC-0156-0000-0009 after Long-Term Exposure in Patients with Haemophilia B

Primary Objective: To evaluate the immunogenicity of N9-GPKey Secondary Objectives:* To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of N9-GP* To evaluate clinical efficacy of N9-GP in long term bleeding prophylaxis (…

Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS study)
Randomised Controlled Trial

To study whether preoperative transfusion increases or decreases the likelihood of having problems after surgery

A randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)

Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…

A multi-center, phase III, non-controlled, open-label trial to evaluate the pharmacokinetics, safety, and efficacy of BAY 94-9027 for prophylaxis and treatment of bleeding in previously treated children (age < 12 years) with severe hemophilia A.

Main objectives: safety and efficacy of BAY94-9027 for prophylaxis and treatment of bleeding in PTP with hemophilia ASecondary objective: PK

What is the optimal antithrombotic strategy in patients presenting with acute coronary syndrome having atrial fibrillation with indication for anticoagulants?

1. To investigate the efficacy of dual therapy (omitting acetylsalicylic acid) compared to triple therapy in patients with atrial fibrillation and acute coronary syndrome.2. To investigate the safety of dual therapy (omitting acetylsalicylic acid)…