Text Size

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

This study is currently recruiting participants.
Verified July 2012 by Ottawa Hospital Research Institute
Sponsor:
Collaborators:
Canadian Blood Services
The Ottawa Hospital
Hamilton Health Sciences Corporation
London Health Sciences Centre
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01237639
First received: October 13, 2010
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  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 2

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:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    We will

    1. Identify logistical issues related to protocol implementation.

      Further, we will evaluate feasibility of:

    2. Recruitment rates,
    3. Randomization implementation strategy,
    4. Data collection of clinical outcomes and
    5. Defining the sample size required for a definitive trial.


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 ]
  • Quality of Life [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    FACT-BMT EQ-5D

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

Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237639

Contacts
Contact: Jason Tay, MD FRCPC MSc 613-737-8899 ext 73034 jtay@ottawahospital.on.ca

Locations
Canada, Ontario
Hamilton Health Sciences Centre Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Irwin Walker, MD     905-521-2100        
Principal Investigator: Irwin Walker, MD            
London Health Sciences Centre, University Hospital Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Anargyros Xenacostas, MD     519-685-8500        
Principal Investigator: Anargyros Xenocostas, MD            
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Jason Tay, MD     613 737 8899 ext 73034     jtay@ottawahospital.on.ca    
Principal Investigator: Jason Tay, MD            
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Blood Services
The Ottawa Hospital
Hamilton Health Sciences Corporation
London Health Sciences Centre
Investigators
Principal Investigator: Jason Tay, MD FRCPC MSc Ottawa Hospital Research Institute
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01237639     History of Changes
Other Study ID Numbers: 2010614-01H
Study First Received: October 13, 2010
Last Updated: July 11, 2012
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013