Cold-stored Platelets for Blood Cancers

(CoVeRTS-HM Trial)

Overseen By Alan Tinmouth, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Anticoagulants

Disqualifiers: Severe thrombocytopenia, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if storing platelets in cold conditions more effectively stops bleeding in people with blood cancers compared to the usual room temperature storage. Platelets, tiny cell fragments in the blood, aid in clotting. Individuals with blood cancers like leukemia often have low platelet counts, leading to bleeding issues. The trial tests two platelet storage methods, including cold-stored platelet concentrate, to identify the more effective option. Individuals with blood cancers, moderate low platelet levels (between 10-100 x10^9/L), and a need for platelet transfusion to stop bleeding may be suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain blood thinners like heparin or warfarin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cold-stored platelets are under investigation for their safety and effectiveness in treating blood cancers and other disorders. Clinical trials are testing their use in patients with low platelet counts and other blood-related conditions. Current studies suggest that cold-stored platelets are generally well-tolerated. However, some risks, such as blood clots in veins or arteries, have been associated with platelet transfusions in cancer patients.

These findings are not final, and researchers continue to gather more information. Since this trial is in its early stages, cold-stored platelets have not yet been fully proven safe for everyone. Those considering joining a trial should discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about cold-stored platelet concentrate because it offers a potentially more effective way to manage blood cancers. Unlike the standard room temperature-stored platelet transfusions, cold-stored platelets might have a longer shelf life and improved function. This could mean more reliable and accessible platelet supplies for patients undergoing treatment, potentially enhancing recovery and reducing complications. Additionally, the cold storage process may preserve the platelets' ability to stop bleeding more effectively, which is crucial for patients with blood cancers.

What evidence suggests that cold-stored platelets could be effective for blood cancers?

Research has shown that platelets stored in the cold might stop bleeding more effectively than those kept at room temperature. In lab studies, cold-stored platelets controlled bleeding better. This trial will compare cold-stored platelet concentrate with room temperature-stored platelet concentrate for patients with blood cancers and low platelet counts. Some studies suggest that cold-stored platelets could benefit those who are actively bleeding. However, further testing is needed to confirm these benefits in real-life situations. ^{1 3 6 7 8}

Who Is on the Research Team?

Johnathan MAck, MD

Principal Investigator

McGill University

Alan Tinmouth, MD

Principal Investigator

OHRI

Are You a Good Fit for This Trial?

Adults over 18 with blood cancers or marrow failure admitted for treatments like chemo, immunotherapy, or stem cell transplant. They must have moderate thrombocytopenia (low platelet count) and need a platelet transfusion to treat bleeding.

Inclusion Criteria

I need a platelet transfusion to stop bleeding.

Moderate thrombocytopenia, platelet concentration 10-100 x109/L

I am an adult with blood cancer or bone marrow failure, receiving treatment or a stem cell transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cold-stored or room temperature-stored platelet transfusions

12 months

Regular visits for transfusion and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including bleeding severity assessment and platelet count monitoring

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cold-stored platelet concentrate

Trial Overview The trial is comparing the effectiveness of cold-stored versus room temperature stored platelets in treating bleeding in patients with hematologic malignancies and low platelet counts.

How Is the Trial Designed?

Group I: Room temperature-stored platelet concentrate Experimental Treatment 1 Intervention

Room temperature-stored, pathogen reduced platelet transfusion

Group II: Cold-stored platelet concentrate Experimental Treatment 1 Intervention

Cold-stored, pathogen-reduced platelet transfusion

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05820126

Cold Versus Room Temperature Storage of Platelets for ... In vitro data suggests that cold-stored platelets have greater hemostatic responsiveness than those stored at room temperature.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05820126/cold-versus-room-temperature-storage-of-platelets-for-bleeding-in-hematologic-malignancy-a-pilot-trial?mp=a...&page=36&id=822&slug=hematologic-neoplasms

Cold Versus Room Temperature Storage of Platelets for ... This study will evaluate the feasibility of a randomized clinical trial comparing cold- and room temperature storage in patients admitted to ...

3. withpower.com withpower.com/trial/phase-2-neoplasms-5-2023-fb21e

Cold-stored Platelets for Blood Cancers (CoVeRTS-HM Trial) ... Cold-stored platelet concentrate will have tolerable side effects & efficacy for patients with Hematologic Malignancies, Bleeding and Blood Cancers. See if ...

4. ashpublications.org ashpublications.org/blood/article/146/17/2023/546600/Chilling-controversy-cold-stored-platelets-for

cold-stored platelets for prophylactic transfusions | Blood Many in vitro studies suggest that cold storage preserves the platelet hemostatic function better than room temperature storage, which could improve transfused ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952791525001219

Potential immune consequences of cold-stored platelet ... The rising interest in using cold-stored platelets (CSP) for improving outcomes in patients with active bleeding has led to multiple clinical trials with ...

6. ashpublications.org ashpublications.org/blood/article/doi/10.1182/blood.2025029252/546600/Chilling-Controversy-Cold-Stored-Platelets-for

cold-stored platelets for prophylactic transfusions | Blood ... platelets in patients with thrombocytopenia and malignant hematologic diseases: a randomized clinical trial ... safety of platelets treated with MIRASOL ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6532779/

Towards increasing shelf life and haemostatic potency of ... In hospitalized cancer patients, platelet transfusion has been linked to a higher risk of venous thromboembolism and arterial thromboembolism as well as an ...

8. researchgate.net researchgate.net/publication/334267828_Therapeutic_Utility_of_Cold-Stored_Platelets_or_Cold-Stored_Whole_Blood_for_the_Bleeding_Hematology-Oncology_Patient

Therapeutic Utility of Cold-Stored Platelets or ... Other recommendations address platelet transfusion in patients with hematologic malignancies or solid tumors or in those who undergo invasive procedures.