Study of Red Blood Cell Transfusion Triggers in Patients Undergoing Hematopoietic Stem Cell Transplantation (TRIST)

Study of Red Blood Cell Transfusion Triggers in Patients Undergoing Hematopoietic Stem Cell Transplantation

Canadian Blood Services, Canadian Institutes of Health Research (CIHR), The Ottawa Hospital, Hamilton Health Sciences Corporation, London Health Sciences Centre, Saskatchewan Cancer Centre

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 : Acute Leukemia, myeloid, lymphoid or biphenotypic in 1st, 2nd remission or in relapse Chronic Myeloid Leukemia in chronic, accelerated or blast phase Chronic Lymphocytic Leukemia Myelodysplastic Syndrome Myeloproliferative Disorder Lymphoma Myeloma All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent.

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.

Inclusion Criteria: Patients are aged 16-70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy Exclusion Criteria: Pregnant or lactating at the time of enrollment Already received red cell transfusion after HSCT but prior to enrollment Unable/unwilling to provide informed consent. Patients receiving HSCT for non-malignancy

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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.