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

Hematologic Malignancies Clinical Trial

— TRIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237639
• Other study ID #: 20120673
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2010
• Last updated: October 11, 2016
• Start date: March 2011
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hematologic Malignancies

Intervention

Other:
• Red blood cell Transfusion
Transfusion of Red blood cells to based on daily complete blood count

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Saskatchewan Cancer Centre	Saskatoon	Saskatchewan

Sponsors (7)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Blood Services, Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation, London Health Sciences Centre, Saskatchewan Cancer Centre, The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

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