Status:
RECRUITING
Bleeding In Thrombocytopenia Explained
Lead Sponsor:
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Conditions:
Hematologic Neoplasms
Bleeding
Eligibility:
All Genders
18+ years
Brief Summary
Multicenter case cohort study investigating clinical risk factors for clinically relevant bleeding in hemato-oncology patients, as well as bleeding related biomarkers during intensive treatment.
Detailed Description
Rationale: Hemato-oncological patients treated with intensive chemotherapy receive prophylactic platelet transfusions to prevent bleeding events as soon as their platelet counts drop below 10 x109/L. ...
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria are mentioned below and differ for part A and B of the study.
- Admission in the hospital. (part A and B)
- Age ≥ 18 years. (part A and B)
AND:
• Hemato-oncology patient, including MDS and AA, admitted for treatment (chemotherapy, SCT) who is (expected to become) thrombocytopenic with platelet counts of < 50 for expected at least 5 days and who will possibly be treated with one or more prophylactic platelet transfusions. (part A and B)
OR:
• Hemato-oncology patient who had previous intensive chemotherapy or stem cell transplantation and who is admitted to the hematology ward for disease or treatment related events or complications. (part A only)
Exclusion Criteria:
• Patients with myeloproliferative disorders.
Key Trial Info
Start Date :
December 4 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03505086
Start Date
December 4 2018
End Date
June 1 2026
Last Update
December 21 2023
Active Locations (1)
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1
LUMC
Leiden, South Holland, Netherlands, 2333 ZA