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

NCT ID: NCT05820126

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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.

Conditions

Hematologic Malignancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cold-stored platelet concentrate

Cold-stored, pathogen-reduced platelet transfusion

Group Type: EXPERIMENTAL

Cold-stored platelet concentrate

Intervention Type: BIOLOGICAL

Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for \>24 hours at 1-6˚C

Room temperature-stored platelet concentrate

Room temperature-stored, pathogen reduced platelet transfusion

Group Type: OTHER

Cold-stored platelet concentrate

Intervention Type: BIOLOGICAL

Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for \>24 hours at 1-6˚C

Interventions

Cold-stored platelet concentrate

Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for \>24 hours at 1-6˚C

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnathan MAck, MD

Role: STUDY_CHAIR

McGill University

Alan Tinmouth, MD

Role: PRINCIPAL_INVESTIGATOR

OHRI

Locations

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Johnathan M Mack, MD

Role: CONTACT

johnathan.mack.med@ssss.gouv.qc.ca

514-934-1934 ext. 42455

Alan Tinmouth, MD

Role: CONTACT

atinmouth@toh.on.ca

613-737-8899 ext. 73914

Facility Contacts

Anne Marie Clement

Role: primary

amclement@ohri.ca

6132955368

Other Identifiers

CoVeRTS-HM

Identifier Type: -

Identifier Source: org_study_id