This is a pilot trial to discover the feasibility of recruiting 50 pts over the course of 12 months. The trial is testing the efficacy of using cold-stored vs. room temperature stored (current standard of care) platelets to treat bleeding in persons with hematological disorders and thrombocytopenia.
Patients with hematologic malignancies or marrow aplasia are at increased risk of bleeding. While prophylactic platelet transfusions reduce the risk of bleeding compared with no prophylaxis, a significant risk of bleeding remains, with 43-54% of patients with a hematologic malignancy or marrow aplasia receiving chemotherapy, immunotherapy, or hematopoietic stem cell transplant (HSCT) experiencing WHO grade 2 or higher bleeding \[Stanworth et al. NEJM 2013; Gernsheimer et al, Blood 2020\]. Improved efficacy of therapeutic platelet transfusions would benefit this patient population. In vitro data suggests that cold-stored platelets have greater hemostatic responsiveness than those stored at room temperature. This study will evaluate the feasibility of a randomized clinical trial comparing cold- and room temperature storage in patients admitted to hospital with a hematologic malignancy or marrow aplasia. Results will inform estimates of transfusion requirements and changes in bleeding severity for power calculations, inform management of a cold-stored platelet inventory, and will provide data on the use of cold-stored platelets in the Canadian health-care setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for \>24 hours at 1-6˚C
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
RECRUITINGAverage Enrollment
1\. The primary feasibility outcome is the average number of patients recruited per month.
Time frame: 12 months
Enrollment Achieved
50 participants enrolled
Time frame: 12 months
Eligible patients consented
Proportion of eligible patients who provide consent
Time frame: 12 months
Non-participation
Reasons for non-participation in eligible patients
Time frame: 12 months
Protocol Adherance
3\. Proportion of patients who complete study procedures and proportion of patients who adhere to the protocol (such as appropriate platelet transfusion, bleeding severity assessment prior to transfusion and at 1-hour, 4 to 6 hours and 18-24 hours after transfusion, platelet count monitoring according to the protocol)
Time frame: 12 months
Withdrawal/ Loss to follow up
Rates of withdrawal and loss to follow-up
Time frame: 12 months
Expired Cold-platelets
Number of cold-stored platelet concentrates that out-date prior to transfusion
Time frame: 12 months
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