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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hematologic Malignancies

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Jason Tay, MD FRCPC MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ottawa Hospital Research Institute

Authority:

Canada: Ethics Review Committee

Study ID:

2010614-01H

NCT ID:

NCT01237639

Start Date:

March 2011

Completion Date:

December 2013

Related Keywords:

  • Hematologic Malignancies
  • Red Cells
  • Transfusion
  • Trigger
  • Threshold
  • Hematopoietic Stem cell Transplantation
  • Neoplasms
  • Hematologic Neoplasms

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