Status:
TERMINATED
Strategies for Transfusion of Platelets (SToP)
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Dartmouth-Hitchcock Medical Center
Haukeland University Hospital
Conditions:
Thrombocytopenia
Eligibility:
All Genders
17+ years
Phase:
PHASE3
Brief Summary
To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.
Detailed Description
BACKGROUND:Platelet transfusions play a major role in the management of thrombocytopenic patients. Platelet transfusions may be given either in the absence of hemorrhage (prophylactic transfusions), o...
Eligibility Criteria
Inclusion
- Patients with hypoproliferative thrombocytopenia who are expected to have a platelet count of ≤ 10,000/µL (10x10\^9/L) for ≥ 10 days (Note: the prophylactic platelet trigger may be higher than10,000/µL (10x10\^9/L) in some participating institutions; however, the patient will still be eligible for participation as long as they are expected to be thrombocytopenic for 10 days)
- Must be an inpatient.
- Weight between 40 and 100 kg.
Exclusion
- Diagnosis of promyelocytic leukemia.
- A history or current diagnosis of immune thrombocytopenia (ITP), thrombotic thrombocytopenia (TTP), or hemolytic uremia syndrome (HUS).
- Evidence of ≥ WHO Grade 2 bleeding while being assessed for the study entry.
- Patients who will receive bedside Leukoreduced platelet transfusions.
- Patients who are pregnant.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00420914
Start Date
October 1 2003
Last Update
May 28 2008
Active Locations (6)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
3
McMaster University
Hamilton, Ontario, Canada, L8N3Z5
4
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 8L6