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

Last updated: July 29, 2025
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Hematologic Neoplasms

Hemorrhage

Neoplasms

Treatment

Cold-stored platelet concentrate

Clinical Study ID

NCT05820126
CoVeRTS-HM
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients (age ≥ 18) admitted to Malignant Hematology ward with hematologicmalignancy or marrow aplasia, this may include patients undergoing chemotherapy,immunotherapy, or hematopoietic stem cell transplant or patients admitted forsymptom management.

  2. Moderate thrombocytopenia, platelet concentration 10-100 x109/L

  3. Platelet transfusion ordered to treat bleeding

Exclusion

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-HMtreatment or outcome

  13. Unable or unwilling to provide informed consent

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Cold-stored platelet concentrate
Phase: 2
Study Start date:
May 16, 2025
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

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