Recruiting
Phase 2

Cold-Stored vs. Room Temperature

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05820126

Conditions

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cold-stored platelet concentrate

Study Details

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.

Conditions

Hematologic Malignancy

Study ID

NCT05820126

Start date

May 16, 2025

Status verified date

Jul, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cold-stored platelet concentrate

Cold-stored, pathogen-reduced platelet transfusion

other: Room temperature-stored platelet concentrate

Room temperature-stored, pathogen reduced platelet transfusion

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

Primary outcome measure

  • Average Enrollment [ Time Frame: 12 months ]
  • Enrollment Achieved [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

  • Hematologic malignancies, bleeding, cold-stored platelets

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-07-31.