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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Biological: Cold-stored platelet concentrate

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Johnathan M Mack, MD; Phone Number: 42455 514-934-1934; Email: johnathan.mack.med@ssss.gouv.qc.ca
• Study Contact Backup: Name: Alan Tinmouth, MD; Phone Number: 73914 613-737-8899; Email: atinmouth@toh.on.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital - General Campus
      • Contact: Anne Marie Clement; Phone Number: 6132955368; Email: amclement@ohri.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold-stored platelet concentrate; Cold-stored, pathogen-reduced platelet transfusion	Biological: 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
Other: Room temperature-stored platelet concentrate; Room temperature-stored, pathogen reduced platelet transfusion	Biological: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Alan Tinmouth, MD, OHRI; Study Chair: Johnathan MAck, MD, McGill University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hematologic malignancies, bleeding, cold-stored platelets
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Hemorrhage
• Other Study ID Numbers: CoVeRTS-HM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No