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Creatine kinase, platelet aggregation, and bleeding risk in women with uterine leiomyomas

Main study:We want to assess whether bleeding risk in women with uterine leiomyomas is associated with CK activity and attenuated platelet aggregation.Objective of pilot study:Firstly, to perform a feasibility pilot of CK/AK measurement in menstrual…

Recovery and survival of platelet concentrates in plasma and in 3 additive solutions

The objectives of this study is to determine the recovery and survival of platelet concentrates; in the first phase, a comparison will be made for platelet concentrates in plasma stored for 2-3 days versus those stored for 6-7 days; in the second…

Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study)

A prospective randomized phase III clinical trial to study the effectiveness of pathogen-reduced platelet concentrates in plasma, stored for up to 7 days, and compare these with untrested platelet concentrates in plasma, stored for up to 7 days. The…

A Phase 1, Prospective, Open Label, Two Period, Fixed Sequence, Dose-Escalation Study of the PK and Safety of BAX 826 (PSA-rFVIII) in Previously Treated Patients with Severe (FVIII <1%) Hemophilia A: Protocol number: 291501

1. To assess tolerability and safety of BAX 826 after a single infusion in previously PTPs with severe hemophilia A.2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE.3. To evaluate the impact of anti- PSA antibodies…

Managing Thrombocyte transfusions in a Special Subgroup: NEonates

To assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in reducing the proportion of patients who experience a major bleed or death up to study day 28.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura).

Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…

Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease.

To test the hypothesis that IVIG treatment diminish the risk of development of chronic disease, we designed a prospective clinical intervention study in children with newly diagnosed ITP.

A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus
Eltrombopag, in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)

Core StudyPrimary objective• To compare the efficacy of E5501 (in addition to standard of care) to eltrombopag (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic…

Platelet transfusions in neonates

Determination of non-inferiority of volume-reduced platelet concentrates compared to plasma platelet concentrate in terms of recovery. To assess safety (bleeding and thrombotic complications, and adverse transfusion reactions) and transfusion…

Regulation of prothrombotic factors in blood of type II diabetes mellitus patients

The objectives of this study are to gain new insights on [1] the cause of a higher clopidogrel resistance in DMII patients[2] the increased production of tissue factor in monocytes in DMII patients

The effect of anagrelide and hydroxyurea on platelet function in patients with Essential Thrombocytosis.
An observational in vitro and ex vivo study on the dynamic conditions of platelet function and (systemic) coagulation activation.

1. To compare the platelet function between healthy controls and patients with ET under both static and dynamic conditions. 2. To study the effects of anagrelide and hydroxyurea on platelet function. 3. To study the intrinsic platelet activation…

Platelet behaviour in Hereditary Thrombocytopathies.
An observational study on the platelet characteristics of a known bleeding disorder with two novel instruments.

To characterise the different platelet activating pathways using the FACS assay and the different steps of primary hemostasis with a perfusion flow model in patients with hereditary thrombocytopathies; Storage Pool Disease (SPD), Glanzmann*s…

Platelet function in minimal extracorporeal circulation versus conventional extracorporeal circulation in coronary artery bypass grafting

This study evaluates if there is a difference in platelet function during and following the use of minimal ECC compared with conventional ECC in coronary artery bypass grafting (CABG) analysed with tromboelastography en multiple electrode aggrometry…

The magnitude of platelet inhibition and the pharmacokinetics of a 600 mg loading dose of clopidogrel, in different patient categories (stable angina versus acute-coronary syndromes versus ST-elevated myocardial infarction).

The primary aim of this MAPCAT-study is to investigate whether pharmacokinetics of clopidogrel differ significantly betwen different clinical scenarios. A second aim is to study specifically whether genetic polymorfisms influence these…

Inhibition of platelet activation by clopidogrel in type II diabetes mellitus patients

The objective of the study is to gain new insights in the causes of a higher clopidogrel resistence in type II diabetes mellitus patients

Platelet function preservation after intraoperative autologous blood donation in cardiac surgery

To reduce postoperative blood loss by improving platelet function in autologous blood donation

Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with Raptiva (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST).

PrimaryTo assess the prevalence of anti-efalizumab positivity in two sub-populations of psoriatic subjects trated with Raptiva® in the framework of the CLEARESTTM study:- Subjects developing adverse events (AEs) corresponding to pre-specified newly…

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

• The primary objective of this study is to establish the efficacy of fostamatinib as compared with placebo in achieving a stable platelet response in subjects with persistent/chronic ITP.• Secondary objectives include assessment of the incidence of…

An international, multicenter, randomized, double-blind, placebocontrolled
phase 3 trial investigating the efficacy and safety of rivaroxaban
to reduce the risk of major thrombotic vascular events in patients with
symptomatic peripheral artery disease undergoing lower extremity
revascularization procedures

The primary efficacy objective of the study is:* to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducingthe risk of major thrombotic vascular events (defined as MI, ischemic stroke, CVdeath, ALI, and major amputation of a…

National study of inherited platelet function disorders in the Netherlands

Primary objective: to register and investigate Dutch patients suspect for an inherited platelet function disorder, to assess clinical presentation, bleeding score, treatment, burden of disease and quality of life. Secondary objectives: to…