NCT01237639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

5.6 years

First QC Date

October 13, 2010

Last Update Submit

October 11, 2016

Conditions

Hematologic Malignancies

Keywords

Red CellsTransfusionTriggerThresholdHematopoietic Stem cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Transplant Related Mortality

    100 days

  • Red Cell Transfusion

    100 days

  • Platelet Transfusion

    100 days

  • Acute Graft Versus Host Disease

    100 days

  • Bleeding

    100 days

  • +4 more secondary outcomes

Study Arms (2)

Restrictive Red blood cell Transfusion

EXPERIMENTAL

Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L

Other: Red blood cell Transfusion

Liberal Red blood Cell Transfusion

ACTIVE COMPARATOR

Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L

Other: Red blood cell Transfusion

Interventions

Red blood cell TransfusionOTHER

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

Liberal Red blood Cell TransfusionRestrictive Red blood cell Transfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are aged 16-70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hamilton Health Sciences Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Saskatchewan Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (4)

  • 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.

    PMID: 21936907BACKGROUND

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • 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.

    PMID: 34932836DERIVED

  • 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.

    PMID: 32083994DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Jason Tay, MD FRCPC MSc

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2010

First Posted

November 9, 2010

Study Start

March 1, 2011

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

CA(4)