Bleeding in patients with hemato-oncological disease in relation to platelet function (BOP study)

Recruiting

Conditions: 10002086
patients with hemato-oncological disease

Registration Number: NL-OMON47418

Lead Sponsor: Meander Medisch Centrum Amersfoort

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

Age * 18 years.
Expected platelet transfusion support (platelet count <50x10^9/L)
Signed informed consent.
Having a hemato-oncological disease receiving high dose chemotherapy or a stem cell transplantation

Exclusion Criteria

Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP
The use of anti-coagulant drugs or drugs affecting platelet function

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: To assess the relation between bleeding tendency (patients<br /><br>with WHO grade II or more) and platelet function and platelet /count. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To assess the relation between bleeding tendency (all grades) and platelet<br /><br>function and platelet count.<br /><br>2. To assess the percentage of days with WHO grade II or more bleeding and<br /><br>platelet function. 3. To assess the relation between vascular damage<br /><br>(endothelial cell markers in plasma) and bleeding tendency (all grades).<br /><br>4. To assess the bleeding observation score, vascular damage and platelet<br /><br>function in patients upon remission-induction chemotherapy for acute leukemia/<br /><br>myelodysplastic syndrome and other diseases.<br /><br>5. To assess the influence of infection (SIRS criteria) on the bleeding<br /><br>observation score, vascular damage and platelet function.<br /><br>6. To assess the influence of platelet transfusions on the health related<br /><br>quality of life in thrombocytopenic hemato-oncological patients. </p><br>