Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
We will Identify logistical issues related to protocol implementation. Further, we will evaluate feasibility of: Recruitment rates, Randomization implementation strategy, Data collection of clinical outcomes and Defining the sample size required for a definitive trial.
2 years
Yes
Jason Tay, MD FRCPC MSc
Principal Investigator
Ottawa Hospital Research Institute
Canada: Ethics Review Committee
2010614-01H
NCT01237639
March 2011
December 2013
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