Cold versus room-temperature platelet storage for treating bleeding in hematologic malignancy

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

This pilot will test whether cold-stored platelets stop bleeding better than room-temperature platelets in adults with hematologic cancers or marrow aplasia who need a platelet transfusion.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT05820126 on ClinicalTrials.gov

What this trial studies

This randomized Phase 2 pilot compares cold-stored versus room-temperature platelet concentrates in adults admitted with hematologic malignancy or marrow aplasia who receive platelets to treat bleeding. The study aims to enroll 50 participants over 12 months at The Ottawa Hospital and will collect data on transfusion requirements, changes in WHO bleeding grade, and logistics of maintaining a cold-stored platelet inventory. Key eligibility includes age ≥18, platelet count 10–100 x10^9/L, and a clinical order for platelet transfusion to treat bleeding, with exclusions for severe thrombocytopenia, platelet refractoriness, therapeutic anticoagulation, and significant coagulopathy. Results will inform feasibility and sample size estimates for a larger randomized trial and provide initial clinical data on cold platelets in the Canadian health-care setting.

Who should consider this trial

Good fit: Adults (≥18) hospitalized at The Ottawa Hospital with a hematologic malignancy or marrow aplasia, platelet count 10–100 x10^9/L, and an order for platelet transfusion to treat bleeding are ideal candidates.

Not a fit: Patients with platelet counts <10 x10^9/L, known platelet refractoriness, therapeutic anticoagulation, significant coagulopathy, congenital bleeding disorders, recent major transfusion, or a history of unprovoked venous thromboembolism are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, cold-stored platelets could improve hemostasis and reduce bleeding severity and transfusion needs for hospitalized patients with hematologic malignancies.

How similar studies have performed: Laboratory studies and small clinical reports suggest cold-stored platelets have greater hemostatic responsiveness, but large randomized clinical trials showing improved bleeding outcomes are limited.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Moderate thrombocytopenia, platelet concentration 10-100 x109/L
3. Platelet transfusion ordered to treat bleeding

Exclusion Criteria:

1. Severe thrombocytopenia (platelet concentration \<10 x 109/L)
2. Known platelet refractoriness requiring HLA or HPA selected platelet concentrates
3. International normalized ratio (INR) \>2.0
4. Activated partial thromboplastin time (aPTT) \>40 seconds
5. Therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant)
6. Known congenital bleeding disorder
7. History of unprovoked venous thromboembolic disease
8. Transfusion of platelet concentrate for \>grade 2 bleeding in preceding 24 hours
9. Order for multiple platelet transfusion at once
10. Refusal of blood transfusion
11. Prior participation in CoVeRTS-HM trial
12. Participation in other clinical trials with interventions that may affect CoVeRTS-HM treatment or outcome
13. Unable or unwilling to provide informed consent

Where this trial is running

Ottawa, Ontario

• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Alan Tinmouth, MD — Ohri
• Study coordinator: Johnathan M Mack, MD

Conditions Hematologic Malignancy; Hematologic malignancies, bleeding, cold-stored platelets