Cardiac SurgeryTRICSIINCT01484639
Transfusion Requirements in Cardiac Surgery
A study testing Liberal transfusion triggers and Restrictive transfusion triggers in people with Cardiac Surgery, run by Nadine Shehata at 8 sites in 2 countries.
Trial summary
This is a multi-centre randomized controlled pilot trial of two transfusion strategies in high risk patients having cardiac surgery. This study will be conducted in 7 Canadian centers and 1 American centre. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Liberal transfusion triggers and Restrictive transfusion triggers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2012to Nov 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 6 or more
- Consent
Who cannot join
- Pregnancy
- Refusal of blood products
- Participating in autologous blood donation program
- Based on the preoperative hemoglobin, the predicted hematocrit on cardiopulmonary bypass is greater than 33% (hemoglobin concentration of 110 g/L) or less than 18% (hemoglobin concentration of 60 g/L)
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Canada7 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Alberta Health Services
Edmonton, Alberta, T6G2B7
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St Michael's Hospital
Toronto, Ontario, M5B1W8
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Transfusion Requirements in Cardiac Surgery (TRICS II): A Randomized Controlled Trial
This is a multi-centre randomized controlled pilot trial of two transfusion strategies in high risk patients having cardiac surgery. This study will be conducted in 7 Canadian centers and 1 American centre. Patients allocated to a "restrictive" transfusion strategy will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward.
The primary objectives of this study are to determine 1) enrollment rates (patients enrolled/patients eligible), 2) consent rates (consent obtained/patients approached); and 3) protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions). The secondary objectives are to determine 1) the mortality rate and the rate of the composite outcome for morbidity of renal, cardiac, neurological and infectious adverse events; 2) the proportion of missing data as a measure of the feasibility of the case report form; and 3) the proportion of blood products utilized (red cells, platelets and plasma).
The results of the multicentre pilot study will be used to 1) maximize enrollment rates to ensure timely completion of recruitment of a definitive large randomized controlled trial, 2) maximize adherence rates, 3) determine event rates for sample size estimation for a definitive study, and to 4) optimize the case report form.
- Conditions
- Cardiac Surgery
- Being tested
- Liberal transfusion triggers, Restrictive transfusion triggers
- Keywords
- transfusion, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal transfusion triggersOther
Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward.
Restrictive transfusion triggersOther
Patients allocated to a "restrictive" transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive transfusion triggers | Active comparator | Patients allocated to a "restrictive" transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. Receives: Other: Restrictive transfusion triggers |
| Liberal transfusion triggers | Active comparator | Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward. Receives: Other: Liberal transfusion triggers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
To determine enrollment rates (patients enrolled/patients eligible), consent rates (consent obtained/patients approached)
Measured: baseline
Protocol adherence
To determine protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions).
Measured: 28 days or hospital discharge
Secondary outcomes (3)
Mortality and morbidity
To determine the mortality rate and a composite outcome for morbidity (renal, cardiac, neurological and infectious adverse events).
Measured: 28 days or hospital discharge
Missing data
To determine the proportion of missing data as a measure of the feasibility of the case report form
Measured: 28 days or hospital discharge
Blood product utilization
To determine the proportion of blood products utilized (red cells, platelets and plasma)
Measured: 28 days or hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionNov 2012
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 Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nadine Shehata
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Canada
- Responsible party
- Sponsor-investigator, Nadine Shehata, Unity Health Toronto
- Investigators
- Nadine Shehata, MD, Principal investigator, Li Ka Shing Knowledge Institute, Mount Sinai HospitalDavid Mazer, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484639
- Sponsor's protocol ID
- TRICSII
- Other IDs
- Application #232416
- Acronym
- TRICSII
- Status last verified
- Feb 2013
- First submitted
- 30 Nov 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Requirements in Cardiac Surgery (TRICS II): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01484639
- Acronym / sponsor ID
- TRICSII / TRICSII
- Conditions
- Cardiac Surgery
- Keywords
- transfusion, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Nadine ShehataUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Canada
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Dec 2011 (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.
This is a multi-centre randomized controlled pilot trial of two transfusion strategies in high risk patients having cardiac surgery. This study will be conducted in 7 Canadian centers and 1 American centre. Patients allocated to a "restrictive" transfusion strategy will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward.
The primary objectives of this study are to determine 1) enrollment rates (patients enrolled/patients eligible), 2) consent rates (consent obtained/patients approached); and 3) protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions). The secondary objectives are to determine 1) the mortality rate and the rate of the composite outcome for morbidity of renal, cardiac, neurological and infectious adverse events; 2) the proportion of missing data as a measure of the feasibility of the case report form; and 3) the proportion of blood products utilized (red cells, platelets and plasma).
The results of the multicentre pilot study will be used to 1) maximize enrollment rates to ensure timely completion of recruitment of a definitive large randomized controlled trial, 2) maximize adherence rates, 3) determine event rates for sample size estimation for a definitive study, and to 4) optimize the case report form.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive transfusion triggers | Active comparator | Other: Restrictive transfusion triggersPatients allocated to a "restrictive" transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. |
| Liberal transfusion triggers | Active comparator | Other: Liberal transfusion triggersPatients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 6 or more
- Consent
Key exclusion criteria (4 listed)
- Pregnancy
- Refusal of blood products
- Participating in autologous blood donation program
- Based on the preoperative hemoglobin, the predicted hematocrit on cardiopulmonary bypass is greater than 33% (hemoglobin concentration of 110 g/L) or less than 18% (hemoglobin concentration of 60 g/L)
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 |
|---|---|---|
| Liberal transfusion triggersPatients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward. | Other | Liberal transfusion triggers |
| Restrictive transfusion triggersPatients allocated to a "restrictive" transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. | Other | Restrictive transfusion triggers |
Primary outcome
Enrollment rate
Time frame: baseline
To determine enrollment rates (patients enrolled/patients eligible), consent rates (consent obtained/patients approached)
Protocol adherence
Time frame: 28 days or hospital discharge
To determine protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions).
3 secondary outcomes
Mortality and morbidity
Time frame: 28 days or hospital discharge
Missing data
Time frame: 28 days or hospital discharge
Blood product utilization
Time frame: 28 days or hospital discharge
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 21 Feb 2013.
- 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.
Nadine Shehata, MD principal investigator
Li Ka Shing Knowledge Institute, Mount Sinai Hospital
David Mazer, MD principal investigator
Unity Health Toronto
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberal transfusion triggers and Restrictive transfusion triggers in people with Cardiac Surgery, run by Nadine Shehata at 8 sites in 2 countries.
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 3 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 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, United States. 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?
Enrollment rate (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT01484639, 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 21 Feb 2013.