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

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ClinicalTrials.gov Identifier: NCT01237639
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : October 12, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Other: Red blood cell Transfusion Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study
Study Start Date : March 2011
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Restrictive Red blood cell Transfusion
Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L
Other: Red blood cell Transfusion
Transfusion of Red blood cells to based on daily complete blood count
Active Comparator: Liberal Red blood Cell Transfusion
Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L
Other: Red blood cell Transfusion
Transfusion of Red blood cells to based on daily complete blood count

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Transplant Related Mortality [ Time Frame: 100 days ]
  2. Red Cell Transfusion [ Time Frame: 100 days ]
  3. Platelet Transfusion [ Time Frame: 100 days ]
  4. Acute Graft Versus Host Disease [ Time Frame: 100 days ]
  5. Bleeding [ Time Frame: 100 days ]
    Grade 3 or 4 by WHO scale

  6. Serious Infections [ Time Frame: 100 days ]
    All grade 4 and 5 infections (according to the CTCAE v.4)

  7. Time to Non-relapse Mortality [ Time Frame: 100 days ]
  8. Economic Evaluation/Quality of Life [ Time Frame: 100 days ]

  9. NCI Toxicity Scale [ Time Frame: 100 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237639

Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8N 3Z5
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Saskatchewan
Saskatchewan Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Blood Services
Canadian Institutes of Health Research (CIHR)
The Ottawa Hospital
Hamilton Health Sciences Corporation
London Health Sciences Centre
Saskatchewan Cancer Centre
Principal Investigator: Jason Tay, MD FRCPC MSc Ottawa Hospital Research Institute
More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01237639     History of Changes
Other Study ID Numbers: 20120673
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016

Keywords provided by Ottawa Hospital Research Institute:
Red Cells
Hematopoietic Stem cell Transplantation