AnemiaNCT00318227
Randomized Trial of a Liberal Versus a Restrictive Transfusion Strategy in Elderly Cardiac Surgery Patients
A study testing Blood Transfusion in people with Anemia and Coronary Artery Bypass Surgery, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether a less restrictive strategy of red blood cell transfusion in elderly patients following coronary bypass surgery results in enhanced postoperative recovery as determined by quality of life assessment, exercise tolerance and clinical outcomes. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Anemia, Coronary Artery Bypass Surgery
- What is being tested?
- Blood Transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jun 2004to 23 Feb 2010
- Phase
- Interventional
- 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients >=70 years of age undergoing non-emergency coronary artery bypass surgery
- Initial postoperative hemoglobin level 70-90g/L
Who cannot join
- Patients who are unable to provide informed consent in English
- Patients with preoperative hemoglobin concentrations <100g/L
- Patients who require emergency re-operation
- Patients with intraoperative or postoperative bleeding diathesis
- Patients with postoperative clinical instability (eg. low output state)
- Patients in whom insertion of an intra-aortic balloon pump is required
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre - University Campus
London, Ontario, N6A 5A5
About this study
Official title: Evaluation of a Liberal Versus Restrictive Blood Transfusion Strategy in Elderly Patients Following Coronary Bypass or Aortic Valve Surgery
The purpose of this study is to determine whether a less restrictive strategy of red blood cell transfusion in elderly patients following coronary bypass surgery results in enhanced postoperative recovery as determined by quality of life assessment, exercise tolerance and clinical outcomes.
Two postoperative transfusion strategies:
- Liberal - transfused when Hgb is <100g/L
- Restrictive - transfused when Hgb is <70g/L
- Conditions
- Anemia, Coronary Artery Bypass Surgery
- Being tested
- Blood Transfusion
- Keywords
- Postoperative care, Cardiac Surgery, Blood Transfusion
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TransfusionProcedure or surgery
Blood transfusion will be administered when the transfusion trigger is met.
| Study group | Role | What they receive |
|---|---|---|
| Liberal Red cell transfusion arm | Active comparator | Transfusion if Hgb <100g/L Receives: Procedure: Blood Transfusion |
| Restrictive Red Cell transfusion | Active comparator | Transfusion if Hgb <70g/L Receives: Procedure: Blood Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked during 6 minute walk test at 5 weeks postop
Measured: 5 weeks
Secondary outcomes (1)
renal failure, hospital length of stay, Quality of Life questionnaire
Measured: during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study start21 Jun 2004
- Primary completion21 Apr 2009
- Study completion23 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Lee Myers, MD FRCSC, Principal investigator, London Health Sciences Centre/University of Western OntarioRobin Varghese, MD MS FRCSC, Principal investigator, London Health Sciences Centre/University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318227
- Sponsor's protocol ID
- R-03-043
- Other IDs
- 9540
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2006
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41114449
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Liberal Versus Restrictive Blood Transfusion Strategy in Elderly Patients Following Coronary Bypass or Aortic Valve Surgery
- ClinicalTrials.gov ID
- NCT00318227
- Acronym / sponsor ID
- R-03-043
- Conditions
- Anemia, Coronary Artery Bypass Surgery
- Keywords
- Postoperative care, Cardiac Surgery, Blood Transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 21 Jun 2004 (actual)
- Primary completion
- 21 Apr 2009 (actual)
- Study completion
- 23 Feb 2010 (actual)
- First posted
- 26 Apr 2006 (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.
The purpose of this study is to determine whether a less restrictive strategy of red blood cell transfusion in elderly patients following coronary bypass surgery results in enhanced postoperative recovery as determined by quality of life assessment, exercise tolerance and clinical outcomes.
Two postoperative transfusion strategies:
- Liberal - transfused when Hgb is <100g/L
- Restrictive - transfused when Hgb is <70g/L
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal Red cell transfusion arm | Active comparator | Procedure: Blood TransfusionTransfusion if Hgb <100g/L |
| Restrictive Red Cell transfusion | Active comparator | Procedure: Blood TransfusionTransfusion if Hgb <70g/L |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients >=70 years of age undergoing non-emergency coronary artery bypass surgery
- Initial postoperative hemoglobin level 70-90g/L
Key exclusion criteria (6 listed)
- Patients who are unable to provide informed consent in English
- Patients with preoperative hemoglobin concentrations <100g/L
- Patients who require emergency re-operation
- Patients with intraoperative or postoperative bleeding diathesis
- Patients with postoperative clinical instability (eg. low output state)
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 |
|---|---|---|
| Blood TransfusionBlood transfusion will be administered when the transfusion trigger is met. | Procedure or surgery | Liberal Red cell transfusion arm, Restrictive Red Cell transfusion |
Primary outcome
Distance walked during 6 minute walk test at 5 weeks postop
Time frame: 5 weeks
1 secondary outcome
renal failure, hospital length of stay, Quality of Life questionnaire
Time frame: during hospital stay
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 28 Aug 2017.
- 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.
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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.
Mary Lee Myers, MD FRCSC principal investigator
London Health Sciences Centre/University of Western Ontario
Robin Varghese, MD MS FRCSC principal investigator
London Health Sciences Centre/University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Transfusion in people with Anemia and Coronary Artery Bypass Surgery, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site 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 2 inclusion and 6 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 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Distance walked during 6 minute walk test at 5 weeks postop (time frame: 5 weeks). 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 NCT00318227, which also lists 1 linked publication.
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 28 Aug 2017.