Clinical trial NCT01237639: Study of Red Blood Cell Transfusion Triggers in Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematologic Malignancies
Keywords: Red Cells
Transfusion
Trigger
Threshold
Hematopoietic Stem cell Transplantation
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Blood Services
name: Canadian Institutes of Health Research (CIHR)
name: The Ottawa Hospital
name: Hamilton Health Sciences Corporation
name: London Health Sciences Centre
name: Saskatchewan Cancer Centre
First posted: 2010-11-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Quality of Life (QOL)/Function based on the FACT-BMT scale
timeFrame: 3 years
Secondary outcomes:
measure: Transplant Related Mortality
timeFrame: 100 days
measure: Red Cell Transfusion
timeFrame: 100 days
measure: Platelet Transfusion
timeFrame: 100 days
measure: Acute Graft Versus Host Disease
timeFrame: 100 days
measure: Bleeding
timeFrame: 100 days
measure: Serious Infections
timeFrame: 100 days
measure: Time to Non-relapse Mortality
timeFrame: 100 days
measure: Economic Evaluation/Quality of Life
timeFrame: 100 days
measure: NCI Toxicity Scale
timeFrame: 100 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatchewan Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Jason Tay, MD FRCPC MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
citation: 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.