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| Name | Class |
|---|---|
| Canadian Blood Services | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| The Ottawa Hospital | OTHER |
| Hamilton Health Sciences Corporation |
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Transfusion of red blood cells (RBCs) is important for the care of patients undergoing stem cell transplantation. Stem cell transplants are used to treat blood cancers and bone marrow disorders. This involves the use of high doses of chemotherapy and/or radiation to kill cancer cells; but this damages the marrow and blood system. Blood stem cells are transplanted by infusing into the recipient and blood counts recover over 2-3 weeks. Before bone marrow recovery, RBCs are needed to support the patient. Higher hemoglobin in these high risk patients may have benefits such as better energy and organ function. However, research in other areas of medicine suggests that a higher red cell count may be dangerous. Taken together, it is unclear whether having a lower or higher red cell count is better for patients having a blood stem cell transplant. The investigators plan to study this by randomly assigning patients having a transplant to be transfused with RBCs either at a higher or lower hemoglobin level. In this way, the investigators will be able to accurately find out if there are any benefits or harms in having a lower or higher red cell count during the recovery period after blood stem cell transplantation.
Males or females aged 18 years or older who are undergoing either an autologous or allogeneic HSCT.
The indications for HSCT may include, but not limited to the following diseases :
All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restrictive Red blood cell Transfusion | Experimental | Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L |
|
| Liberal Red blood Cell Transfusion | Active Comparator | Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood cell Transfusion | Other | Transfusion of Red blood cells to based on daily complete blood count |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL)/Function based on the FACT-BMT scale | The FACT consists of 5 subscales that measure physical well-being, functional well-being, social/family well-being and emotional well-being. The BMT subscale of the FACT includes additional items specifically designed to test quality of life and symptoms specific to BMT patients. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant Related Mortality | 100 days | |
| Red Cell Transfusion | 100 days | |
| Platelet Transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Tay, MD FRCPC MSc | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences Centre | Hamilton | Ontario | L8N 3Z5 | Canada | ||
| London Health Sciences Centre, University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21936907 | Background | Tay J, Tinmouth A, Fergusson D, Allan D. Transfusion of red cells in hematopoietic stem cell transplantation (TRIST): study protocol for a randomized controlled trial. Trials. 2011 Sep 21;12:207. doi: 10.1186/1745-6215-12-207. | |
| 41114449 | Derived | Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| OTHER |
| London Health Sciences Centre | OTHER |
| Saskatchewan Cancer Centre | UNKNOWN |
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| 100 days |
| Acute Graft Versus Host Disease | 100 days |
| Bleeding | Grade 3 or 4 by WHO scale | 100 days |
| Serious Infections | All grade 4 and 5 infections (according to the CTCAE v.4) | 100 days |
| Time to Non-relapse Mortality | 100 days |
| Economic Evaluation/Quality of Life | EQ-5D | 100 days |
| NCI Toxicity Scale | 100 days |
| London |
| Ontario |
| N6A 5A5 |
| Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Saskatchewan Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| 34932836 | Derived | Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5. |
| 32083994 | Derived | Tay J, Allan DS, Chatelain E, Coyle D, Elemary M, Fulford A, Petrcich W, Ramsay T, Walker I, Xenocostas A, Tinmouth A, Fergusson D. Liberal Versus Restrictive Red Blood Cell Transfusion Thresholds in Hematopoietic Cell Transplantation: A Randomized, Open Label, Phase III, Noninferiority Trial. J Clin Oncol. 2020 May 1;38(13):1463-1473. doi: 10.1200/JCO.19.01836. Epub 2020 Feb 21. |