NCT05820126 Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial
| NCT ID | NCT05820126 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-05-16 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Johnathan MAck, MD
STUDY CHAIR
McGill University
Frequently Asked Questions
Who can join the NCT05820126 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05820126 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05820126 currently recruiting?
Yes, NCT05820126 is actively recruiting participants. Contact the research team at johnathan.mack.med@ssss.gouv.qc.ca for enrollment information.
Where is the NCT05820126 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT05820126 clinical trial?
NCT05820126 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Johnathan MAck, MD at McGill University. The trial plans to enroll 50 participants.