At a glance
ClinicalIndex Comparison Record- ✓Hypoproliferative thrombocytopenia with expected platelet count ≤10,000/μL for at least 5 days and expected hospitalization ≥5 days
- ✓Weight between 10-135 kg
- ✓Coagulation parameters within normal limits: PT ≤1.3× ULN, PTT ≤1.3× ULN, fibrinogen ≥100 mg/dL (measured within 72 hours)
- ✓Undergoing or completed hematopoietic stem cell transplantation (any diagnosis) OR hematologic malignancy (acute/chronic leukemia, lymphoma, myeloma, myelodysplasia) undergoing/completed chemotherapy OR non-hematologic malignancy undergoing/completed chemotherapy
- ✕Grade ≥2 bleeding (by Platelet Dose Trial Bleeding Scale)
- ✕Currently receiving antithrombotic drugs
- ✕Will receive bedside leuko-reduced platelet transfusions
- ✕History of platelet transfusion refractoriness within 30 days prior to study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients (A TMH CTN Study)
In Brief
A Phase 3 clinical trial evaluating Medium Dose Prophylactic Platelet Transfusions, Lower Dose Prophylactic Platelet Transfusions, and 1 other intervention for Thrombocytopenia. Completed, enrolled 1,351 participants across 21 sites.
Detailed Summary
The primary objective of this study is to compare the three study arms of lower, medium, and higher dose platelet therapy with respect to the percentage of patients experiencing at least one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding Scale (Grade 2 bleeding corresponds to bleeding that is moderate, but not severe enough to warrant red blood cell transfusion). There are a number of secondary endpoints related to platelet transfusions, hemostasis, and other concerns. The four most important secondary endpoints will compare the three study arms with respect to the following outcomes: 1) platelet utilization rates (total number of platelets transfused x 10 \^11); 2) number of platelet transfusion events (frequency of transfusions); a transfusion event would be defined as each separate platelet transfusion issued by the study site's transfusion service; 3) highest category of bleeding during time of study (Platelet Dose Trial Bleeding Scale Grades less than or equal to 1, 2, 3, or 4 by arm); and 4) bleeding severity based on number of days with bleeding (total days of bleeding and bleeding/thrombocytopenic day), intensity of bleeding, and number of sites with bleeding (if such a severity score has been validated and published by the time the study is completed).
Study Details
Timeline
Interventions
2.2 x 10\^11 platelets per m\^2 BSA
1.1 x 10\^11 platelets per m\^2 BSA
4.4 \* 10\^11 platelets per m\^2 BSA