Cold versus room-temperature platelet storage for treating bleeding in hematologic malignancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 pilot compares cold-stored versus room-temperature platelet concentrates in adults admitted with hematologic malignancy or marrow aplasia who receive platelets to treat bleeding. The study aims to enroll 50 participants over 12 months at The Ottawa Hospital and will collect data on transfusion requirements, changes in WHO bleeding grade, and logistics of maintaining a cold-stored platelet inventory. Key eligibility includes age ≥18, platelet count 10–100 x10^9/L, and a clinical order for platelet transfusion to treat bleeding, with exclusions for severe thrombocytopenia, platelet refractoriness, therapeutic anticoagulation, and significant coagulopathy. Results will inform feasibility and sample size estimates for a larger randomized trial and provide initial clinical data on cold platelets in the Canadian health-care setting.

Why it matters

Who can join: the full rules

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

Where it's running

• The Ottawa Hospital - General Campus
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Alan Tinmouth, MD — Ohri
• Study coordinator: Johnathan M Mack, MD
• Email: johnathan.mack.med@ssss.gouv.qc.ca
• Phone: 514-934-1934

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High-dose vs standard-dose flu vaccine in adults with blood cancers on B-cell-depleting therapy

  This study tests whether a high-dose flu shot evokes a stronger immune response than a standard-dose shot in adults with hematologic cancers who recently had B-cell-depleting therapy.

  Recruiting Phase 2 Asan Medical Center · Seoul · NCT07926217

• CD45RA-depleted donor cells to help fight stubborn viral infections after haploidentical transplant

  This trial tests whether giving patients specially prepared donor immune cells (CD45RA-depleted DLI) can help clear viral infections that linger after a stem cell transplant and who have not fully recovered their immunity.

  Recruiting Phase 1/2 Ruijin Hospital · Shanghai, SH · NCT07662369

• Identifying biomarkers for CAR-T cell therapy in cancer patients

  This study looks at real-world CAR-T therapy in adults with blood cancers to see which biomarkers predict who responds or relapses.

  Recruiting University Hospital, Lille · Lille and 1 other locations · NCT07609485

• QH101 Vδ2 T-cell therapy for adults with relapsed or advanced malignant tumors

  This study will try QH101, an off-the-shelf Vδ2 T-cell therapy, in adults with relapsed or advanced blood cancers or solid tumors to see if it is safe and helps fight tumors.

  Recruiting Phase 1/2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07570563

• Short versus long maribavir treatment after allogeneic stem cell transplant

  This trial tests whether a shorter or longer course of maribavir helps adults with refractory CMV infection after their first allogeneic stem cell transplant.

  Recruiting Phase 3 Ruijin Hospital · Shanghai · NCT07511127

• Seeing if DCog Short on an iPad can spot neurotoxicity in CAR-T patients

  This study tests whether a self-report iPad tool called DCog Short can help identify neurotoxicity in people receiving CAR-T cell therapy.

  Recruiting Beth Israel Deaconess Medical Center · Boston, Massachusetts · NCT07403812

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.