Hematologic MalignanciesPhase 3TRISTNCT01237639
Study of Red Blood Cell Transfusion Triggers in Patients Undergoing Hematopoietic Stem Cell Transplantation
A Phase 3 study testing Red blood cell Transfusion in people with Hematologic Malignancies, run by Ottawa Hospital Research Institute at 4 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Red blood cell Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesCanada
- Study dates
- Mar 2011to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are aged 16-70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Hamilton Health Sciences Centre
Hamilton, Ontario, L8N 3Z5
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Saskatchewan Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
About this study
Official title: Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study
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.
Read the detailed description
- Males or females aged 18 years or older who are undergoing either an autologous or allogeneic HSCT.
- The indications for HSCT may include, but not limited to the following diseases :
- Acute Leukemia, myeloid, lymphoid or biphenotypic in 1st, 2nd remission or in relapse
- Chronic Myeloid Leukemia in chronic, accelerated or blast phase
- Chronic Lymphocytic Leukemia
- Myelodysplastic Syndrome
- Myeloproliferative Disorder
- Lymphoma
- Myeloma
- All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent.
- Conditions
- Hematologic Malignancies
- Being tested
- Red blood cell Transfusion
- Keywords
- Red Cells, Transfusion, Trigger, Threshold, Hematopoietic Stem cell Transplantation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell TransfusionOther
Transfusion of Red blood cells to based on daily complete blood count
| Study group | Role | What they receive |
|---|---|---|
| Restrictive Red blood cell Transfusion | Experimental | Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L Receives: 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 Receives: Other: Red blood cell Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (9)
Transplant Related Mortality
Measured: 100 days
Red Cell Transfusion
Measured: 100 days
Platelet Transfusion
Measured: 100 days
Acute Graft Versus Host Disease
Measured: 100 days
Bleeding
Grade 3 or 4 by WHO scale
Measured: 100 days
Serious Infections
All grade 4 and 5 infections (according to the CTCAE v.4)
Measured: 100 days
Time to Non-relapse Mortality
Measured: 100 days
Economic Evaluation/Quality of Life
EQ-5D
Measured: 100 days
NCI Toxicity Scale
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Blood Services, Canadian Institutes of Health Research (CIHR), The Ottawa Hospital, Hamilton Health Sciences Corporation, London Health Sciences Centre, Saskatchewan Cancer Centre
- Responsible party
- Sponsor
- Investigators
- Jason Tay, MD FRCPC MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237639
- Sponsor's protocol ID
- 20120673
- Acronym
- TRIST
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2010
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21936907Carson 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.
PubMed 41114449Carson 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.
PubMed 34932836Tay 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.
PubMed 32083994
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study
- ClinicalTrials.gov ID
- NCT01237639
- Acronym / sponsor ID
- TRIST / 20120673
- Conditions
- Hematologic Malignancies
- Keywords
- Red Cells, Transfusion, Trigger, Threshold, Hematopoietic Stem cell Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Blood Services, Canadian Institutes of Health Research (CIHR), The Ottawa Hospital, Hamilton Health Sciences Corporation, London Health Sciences Centre, Saskatchewan Cancer Centre
- Study start
- Mar 2011
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Males or females aged 18 years or older who are undergoing either an autologous or allogeneic HSCT.
- The indications for HSCT may include, but not limited to the following diseases :
- Acute Leukemia, myeloid, lymphoid or biphenotypic in 1st, 2nd remission or in relapse
- Chronic Myeloid Leukemia in chronic, accelerated or blast phase
- Chronic Lymphocytic Leukemia
- Myelodysplastic Syndrome
- Myeloproliferative Disorder
- Lymphoma
- Myeloma
- All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive Red blood cell Transfusion | Experimental | Other: Red blood cell TransfusionTransfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L |
| Liberal Red blood Cell Transfusion | Active comparator | Other: Red blood cell TransfusionTransfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are aged 16-70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell TransfusionTransfusion of Red blood cells to based on daily complete blood count | Other | Liberal Red blood Cell Transfusion, Restrictive Red blood cell Transfusion |
Primary outcome
Quality of Life (QOL)/Function based on the FACT-BMT scale
Time frame: 3 years
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.
9 secondary outcomes
Transplant Related Mortality
Time frame: 100 days
Red Cell Transfusion
Time frame: 100 days
Platelet Transfusion
Time frame: 100 days
Acute Graft Versus Host Disease
Time frame: 100 days
Bleeding
Time frame: 100 days
Serious Infections
Time frame: 100 days
Time to Non-relapse Mortality
Time frame: 100 days
Economic Evaluation/Quality of Life
Time frame: 100 days
NCI Toxicity Scale
Time frame: 100 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Background: PubMed 21936907Tay 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.
- Derived from this study: PubMed 41114449Carson 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.
- Derived from this study: PubMed 34932836Carson 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.
- Derived from this study: PubMed 32083994Tay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Tay, MD FRCPC MSc principal investigator
Ottawa Hospital Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Red blood cell Transfusion in people with Hematologic Malignancies, run by Ottawa Hospital Research Institute at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QOL)/Function based on the FACT-BMT scale (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237639, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.