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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold-stored platelet concentrate | Experimental | Cold-stored, pathogen-reduced platelet transfusion |
|
| Room temperature-stored platelet concentrate | Other | Room temperature-stored, pathogen reduced platelet transfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold-stored platelet concentrate | Biological | Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for >24 hours at 1-6ËšC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Enrollment | 1. The primary feasibility outcome is the average number of patients recruited per month. | 12 months |
| Enrollment Achieved | 50 participants enrolled | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Eligible patients consented | Proportion of eligible patients who provide consent | 12 months |
| Non-participation | Reasons for non-participation in eligible patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johnathan M Mack, MD | Contact | 514-934-1934 | 42455 | johnathan.mack.med@ssss.gouv.qc.ca |
| Alan Tinmouth, MD | Contact | 613-737-8899 | 73914 | atinmouth@toh.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Johnathan MAck, MD | McGill University | Study Chair |
| Alan Tinmouth, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital - General Campus | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Single center, Blinded, Randomized Controlled Trial
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The investigator and participant will both be blinded to the study treatment (whether they receive cold stored vs. room temperature stored platelets). The clinical staff who will administer the platelets and complete the bleeding assessment tool will not be informed of the group assignment. The outcome assessors/adjudication committee will be blinded.
| 12 months |
| Protocol Adherance | 3. 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) | 12 months |
| Withdrawal/ Loss to follow up | Rates of withdrawal and loss to follow-up | 12 months |
| Expired Cold-platelets | Number of cold-stored platelet concentrates that out-date prior to transfusion | 12 months |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |