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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01237639
Acronym
TRIST
Enrollment
300
Registered
2010-11-09
Start date
2011-03-31
Completion date
2016-10-31
Last updated
2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies

Keywords

Red Cells, Transfusion, Trigger, Threshold, Hematopoietic Stem cell Transplantation

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.

Interventions

OTHERRed blood cell Transfusion

Transfusion of Red blood cells to based on daily complete blood count

Sponsors

Canadian Blood Services
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
The Ottawa Hospital
CollaboratorOTHER
Hamilton Health Sciences Corporation
CollaboratorOTHER
London Health Sciences Centre
CollaboratorOTHER
Saskatchewan Cancer Centre
CollaboratorUNKNOWN
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life (QOL)/Function based on the FACT-BMT scale3 yearsThe 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.

Secondary

MeasureTime frameDescription
Red Cell Transfusion100 days
Platelet Transfusion100 days
Acute Graft Versus Host Disease100 days
Bleeding100 daysGrade 3 or 4 by WHO scale
Transplant Related Mortality100 days
Time to Non-relapse Mortality100 days
Economic Evaluation/Quality of Life100 daysEQ-5D
NCI Toxicity Scale100 days
Serious Infections100 daysAll grade 4 and 5 infections (according to the CTCAE v.4)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026