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

Hematologic Malignancies Clinical Trial

Official title: Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

1. Males or females aged 18 years or older who are undergoing either an autologous or allogeneic HSCT.

2. The indications for HSCT may include, but not limited to the following diseases :

1. Acute Leukemia, myeloid, lymphoid or biphenotypic in 1st, 2nd remission or in relapse

2. Chronic Myeloid Leukemia in chronic, accelerated or blast phase

3. Chronic Lymphocytic Leukemia

4. Myelodysplastic Syndrome

5. Myeloproliferative Disorder

6. Lymphoma

7. Myeloma

3. All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematologic Malignancies

• NCT number: NCT01237639
• Study type: Interventional
• Source: Ottawa Hospital Research Institute
• Status: Completed
• Phase: Phase 3
• Start date: March 2011
• Completion date: October 2016