Hematologic MalignancyPhase 2CoVeRTS-HMNCT05820126
Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial
A Phase 2 study testing Cold-stored platelet concentrate in people with Hematologic Malignancy, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Cold-stored platelet concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Moderate thrombocytopenia, platelet concentration 10-100 x109/L
- Platelet transfusion ordered to treat bleeding
Who cannot join
- Severe thrombocytopenia (platelet concentration <10 x 109/L)
- Known platelet refractoriness requiring HLA or HPA selected platelet concentrates
- International normalized ratio (INR) >2.0
- Activated partial thromboplastin time (aPTT) >40 seconds
- Therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant)
- Known congenital bleeding disorder
Show all 13Show fewer
- History of unprovoked venous thromboembolic disease
- Transfusion of platelet concentrate for >grade 2 bleeding in preceding 24 hours
- Order for multiple platelet transfusion at once
- Refusal of blood transfusion
- Prior participation in CoVeRTS-HM trial
- Participation in other clinical trials with interventions that may affect CoVeRTS-HM treatment or outcome
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Anne Marie Clement, 6132955368, amclement@ohri.ca
About this study
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.
Read the 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.
- Conditions
- Hematologic Malignancy
- Being tested
- Cold-stored platelet concentrate
- Keywords
- Hematologic malignancies, bleeding, cold-stored platelets
- Medical subject headings
- Hematologic Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold-stored platelet concentrateBiological
Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for >24 hours at 1-6˚C
| Study group | Role | What they receive |
|---|---|---|
| Cold-stored platelet concentrate | Experimental | Cold-stored, pathogen-reduced platelet transfusion Receives: Biological: Cold-stored platelet concentrate |
| Room temperature-stored platelet concentrate | Other | Room temperature-stored, pathogen reduced platelet transfusion Receives: Biological: Cold-stored platelet concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Enrollment
- The primary feasibility outcome is the average number of patients recruited per month.
Measured: 12 months
Enrollment Achieved
50 participants enrolled
Measured: 12 months
Secondary outcomes (5)
Eligible patients consented
Proportion of eligible patients who provide consent
Measured: 12 months
Non-participation
Reasons for non-participation in eligible patients
Measured: 12 months
Protocol Adherance
- 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)
Measured: 12 months
Withdrawal/ Loss to follow up
Rates of withdrawal and loss to follow-up
Measured: 12 months
Expired Cold-platelets
Number of cold-stored platelet concentrates that out-date prior to transfusion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start16 May 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single center, Blinded, Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johnathan MAck, MD, Study chair, McGill UniversityAlan Tinmouth, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820126
- Sponsor's protocol ID
- CoVeRTS-HM
- Acronym
- CoVeRTS-HM
- Status last verified
- Jul 2025
- First submitted
- 14 Apr 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial
- ClinicalTrials.gov ID
- NCT05820126
- Acronym / sponsor ID
- CoVeRTS-HM / CoVeRTS-HM
- Conditions
- Hematologic Malignancy
- Keywords
- Hematologic malignancies, bleeding, cold-stored platelets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, Blinded, Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Cold-stored platelet concentrate | Experimental | Biological: Cold-stored platelet concentrateCold-stored, pathogen-reduced platelet transfusion |
| Room temperature-stored platelet concentrate | Other | Biological: Cold-stored platelet concentrateRoom temperature-stored, pathogen reduced platelet transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Moderate thrombocytopenia, platelet concentration 10-100 x109/L
- Platelet transfusion ordered to treat bleeding
Key exclusion criteria (13 listed)
- Severe thrombocytopenia (platelet concentration <10 x 109/L)
- Known platelet refractoriness requiring HLA or HPA selected platelet concentrates
- International normalized ratio (INR) >2.0
- Activated partial thromboplastin time (aPTT) >40 seconds
- Therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold-stored platelet concentratePatients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for >24 hours at 1-6˚C | Biological | Cold-stored platelet concentrate, Room temperature-stored platelet concentrate |
Primary outcome
Average Enrollment
Time frame: 12 months
1. The primary feasibility outcome is the average number of patients recruited per month.
Enrollment Achieved
Time frame: 12 months
50 participants enrolled
5 secondary outcomes
Eligible patients consented
Time frame: 12 months
Non-participation
Time frame: 12 months
Protocol Adherance
Time frame: 12 months
Withdrawal/ Loss to follow up
Time frame: 12 months
Expired Cold-platelets
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johnathan MAck, MD study chair
McGill University
Alan Tinmouth, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cold-stored platelet concentrate in people with Hematologic Malignancy, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johnathan M Mack, MD (514-934-1934 ext. 42455, johnathan.mack.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Enrollment (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.