Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Biological: Cold-stored platelet concentrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age ≥ 18) admitted to Malignant Hematology ward with hematologic malignancy or marrow aplasia, undergoing chemotherapy, immunotherapy, or hematopoietic stem cell transplant Moderate thrombocytopenia, platelet concentration 10-100 x109/L Platelet transfusion ordered to treat bleeding Exclusion Criteria: Severe thrombocytopenia (platelet concentration <10 x 109/L) Known platelet refractoriness requiring HLA or HPA selected platelet concentrates International normalized ratio (INR) >2.0 Activated partial thromboplastin time (aPTT) >40 seconds Therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant) Known congenital bleeding disorder History of unprovoked venous thromboembolic disease Transfusion of platelet concentrate for >greade 2 bleeding in preceding 24 hours Order for multiple platelet transfusion at once Refusal of blood transfusion Prior participation in CoVeRTS-HM trial Participation in other clinical trials with interventions that may affect CoVeRTS-HM treatment or outcome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single center, Blinded, Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold-stored platelet concentrate<br>Cold-stored, pathogen-reduced platelet transfusion | Biological: Cold-stored platelet concentrate<br>* Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for >24 hours at 1-6˚C<br>|
| Other: Room temperature-stored platelet concentrate<br>Room temperature-stored, pathogen reduced platelet transfusion | Biological: Cold-stored platelet concentrate<br>* Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for >24 hours at 1-6˚C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Enrollment | 1. The primary feasibility outcome is the average number of patients recruited per month. | 12 months | 
| Enrollment Achieved | 50 participants enrolled | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligible patients consented | Proportion of eligible patients who provide consent | 12 months | 
| Non-participation | Reasons for non-participation in eligible patients | 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) | 12 months | 
| Withdrawal/ Loss to follow up | Rates of withdrawal and loss to follow-up | 12 months | 
| Expired Cold-platelets | Number of cold-stored platelet concentrates that out-date prior to transfusion | 12 months |