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

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.

Inclusion criteria

• Adult patients (age ≥ 18) admitted to Malignant Hematology ward with hematologic malignancy or marrow aplasia, this may include patients undergoing chemotherapy, immunotherapy, or hematopoietic stem cell transplant or patients admitted for symptom management.
• 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 >grade 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
• Unable or unwilling to provide informed consent