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

Overview

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 Title of Study: “Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

Detailed 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.

Interventions

  • Other: Red blood cell Transfusion
    • Transfusion of Red blood cells to based on daily complete blood count

Arms, Groups and Cohorts

  • Experimental: Restrictive Red blood cell Transfusion
    • Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L
  • Active Comparator: Liberal Red blood Cell Transfusion
    • Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L

Clinical Trial Outcome Measures

Primary Measures

  • Quality of Life (QOL)/Function based on the FACT-BMT scale
    • Time Frame: 3 years
    • 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.

Secondary Measures

  • Transplant Related Mortality
    • Time Frame: 100 days
  • Red Cell Transfusion
    • Time Frame: 100 days
  • Platelet Transfusion
    • Time Frame: 100 days
  • Acute Graft Versus Host Disease
    • Time Frame: 100 days
  • Bleeding
    • Time Frame: 100 days
    • Grade 3 or 4 by WHO scale
  • Serious Infections
    • Time Frame: 100 days
    • All grade 4 and 5 infections (according to the CTCAE v.4)
  • Time to Non-relapse Mortality
    • Time Frame: 100 days
  • Economic Evaluation/Quality of Life
    • Time Frame: 100 days
    • EQ-5D
  • NCI Toxicity Scale
    • Time Frame: 100 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ottawa Hospital Research Institute
  • Collaborator
    • Canadian Blood Services
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jason Tay, MD FRCPC MSc, Principal Investigator, Ottawa Hospital Research Institute

References

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.

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