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

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 3

Conditions: Hematologic Malignancies

Treatments: Other: Red blood cell Transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01237639

20120673

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Restrictive Red blood cell Transfusion

Experimental group

Description:

Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L

Treatment:

Other: Red blood cell Transfusion

Liberal Red blood Cell Transfusion

Active Comparator group

Description:

Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L

Treatment:

Other: Red blood cell Transfusion