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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Blood Services
Canadian Institutes of Health Research (CIHR)
The Ottawa Hospital
Hamilton Health Sciences Corporation
London Health Sciences Centre
Saskatchewan Cancer Centre
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01237639
First received: October 13, 2010
Last updated: March 29, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Hematologic Malignancies
Other: Red blood cell Transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Quality of Life (QOL)/Function based on the FACT-BMT scale [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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:
  • Transplant Related Mortality [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • Red Cell Transfusion [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • Platelet Transfusion [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • Acute Graft Versus Host Disease [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • Bleeding [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    Grade 3 or 4 by WHO scale

  • Serious Infections [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    All grade 4 and 5 infections (according to the CTCAE v.4)

  • Time to Non-relapse Mortality [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • Economic Evaluation/Quality of Life [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    EQ-5D

  • NCI Toxicity Scale [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: March 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237639

Locations
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
Investigators
Principal Investigator: Jason Tay, MD FRCPC MSc Ottawa Hospital Research Institute
  More Information

Publications:
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01237639     History of Changes
Other Study ID Numbers: 20120673 
Study First Received: October 13, 2010
Last Updated: March 29, 2016
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 03, 2016