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

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

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancies
• Intervention / Treatment: Other: Red blood cell Transfusion

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton Health Sciences Centre
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre, University Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatchewan Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); The Ottawa Hospital; Hamilton Health Sciences Corporation; London Health Sciences Centre; Canadian Blood Services; Saskatchewan Cancer Centre
• Investigators: Principal Investigator: Jason Tay, MD FRCPC MSc, Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• 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.
• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Dorée C, Hébert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12:CD002042. doi: 10.1002/14651858.CD002042.pub5. Review.
• Tay J, Allan DS, Chatelain E, Coyle D, Elemary M, Fulford A, Petrcich W, Ramsay T, Walker I, Xenocostas A, Tinmouth A, Fergusson D. Liberal Versus Restrictive Red Blood Cell Transfusion Thresholds in Hematopoietic Cell Transplantation: A Randomized, Open Label, Phase III, Noninferiority Trial. J Clin Oncol. 2020 May 1;38(13):1463-1473. doi: 10.1200/JCO.19.01836. Epub 2020 Feb 21.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (Estimate): November 9, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Transfusion; Red Cells; Trigger; Threshold; Hematopoietic Stem cell Transplantation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 20120673

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No