Transfusion Requirements in Cardiac Surgery III
- Conditions
- Disorder; Heart, Functional, Postoperative, Cardiac Surgery
- Interventions
- Other: Restrictive Transfusion StrategyOther: Liberal transfusion strategy
- Registration Number
- NCT02042898
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5028
- Age 18 or older
- Planned cardiac surgery using cardiopulmonary bypass
- Informed consent obtained
- Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more
- Patients who are unable to receive or who refuse blood products
- Patients who are involved in a preoperative autologous pre-donation program
- Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
- Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential.)
- Patients who are unable to receive or who refuse blood products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Restrictive transfusion strategy Restrictive Transfusion Strategy Restrictive transfusion strategy: patients will receive a red cell transfusion if their hemoglobin is \<75 g/L (\<7.5 g/dL;\<4.7mmol/L) intraoperatively and/or postoperatively Liberal transfusion strategy Liberal transfusion strategy Liberal transfusion strategy: patients will receive a red cell transfusion if their hemoglobin concentration is \<95 g/L (\<9.5 g/dL\<5.9mmol/L) intraoperatively, or postoperatively in the intensive care unit; and/or \<85 g/L (\< 8.5 g/dL;\<5.3mmol/L) on the ward.
- Primary Outcome Measures
Name Time Method Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit Up to hospital discharge or postoperative day 28 (whichever occurs first) Composite score of any one of the following events occurring during the index hospitalization (from the start of surgery until hospital discharge or postoperative day 28, whichever comes first): (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit
- Secondary Outcome Measures
Name Time Method Incidence of in-hospital all-cause mortality Up to hospital discharge or postoperative day 28 (whichever occurs first) The proportion of patients transfused and the number of blood products and hemostatic products utilized (e.g. red cells, plasma, platelets, cryoprecipitate, factor VII) (index hospitalization) Up to hospital discharge or postoperative day 28 (whichever occurs first) Incidence of Delirium Up to hospital discharge or postoperative day 28 (whichever occurs first) Incidence of in-hospital myocardial infarction Up to hospital discharge or postoperative day 28 (whichever occurs first) Incidence of in-hospital new renal failure requiring dialysis Up to hospital discharge or postoperative day 28 (whichever occurs first) Incidence of in-hospital new focal neurological deficit Up to hospital discharge or postoperative day 28 (whichever occurs first) Length of stay in the ICU and hospital Up to hospital discharge or postoperative day 28 (whichever occurs first) Prolonged low output state defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump postoperatively or ventricular assist device Up to hospital discharge or postoperative day 28 (whichever occurs first) Duration of mechanical ventilation Up to hospital discharge or postoperative day 28 (whichever occurs first) Incidence of infection Up to hospital discharge or postoperative day 28 (whichever occurs first) Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria) Up to hospital discharge or postoperative day 28 (whichever occurs first) Incidence of gut infarction Up to hospital discharge or postoperative day 28 (whichever occurs first) Death 6 months Stroke 6 months Coronary revascularization 6 months Renal function, based on changes in postoperative serum creatinine Up to hospital discharge or postoperative day 28 (whichever occurs first) Incidence of Seizures Up to hospital discharge or postoperative day 28 (whichever occurs first) Incidence of Encephalopathy Up to hospital discharge or postoperative day 28 (whichever occurs first) New onset dialysis (since incident surgery) status 6 months Myocardial infarction 6 months Health Care Utilization 6 months
Trial Locations
- Locations (74)
Michael E. DeBakey Veterans Affairs Medical Center
🇺🇸Houston, Texas, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
St Vincent's Hospital, Melbourne
🇦🇺Fitzroy, Victoria, Australia
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
University Health Network Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Royal North Shore Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Hospital Unimed Rio (National Institute of Cardiology)
🇧🇷Rio de Janeiro, Brazil
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Hôpital du Sacré-Cœur de Montréal
🇨🇦Montreal, Quebec, Canada
Fundacion Cardioinfantil Instituto de Cardiologia
🇨🇴Bogota, Colombia
Fundación Clínica Shaio
🇨🇴Bogota, Colombia
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
University Hospital Giessen
🇩🇪Giessen, Germany
Waikato Hospital
🇳🇿Hamilton, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Auckland City Hospital
🇳🇿Auckland, New Zealand
Emergency Institute for Cardiovascular Diseases
🇷🇴Târgu-Mureș, Romania
Wellington Hospital
🇳🇿Wellington, New Zealand
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Instituto de Investigación Sanitaria Hospital Univ. & Politc. La Fe de Valencia
🇪🇸Valencia, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
University Hospital Bern (Inselspital)
🇨🇭Bern, Switzerland
Shanghai Yodak Cardio-Thoracic Hospital
🇨🇳Shanghai, China
Renji Hospital
🇨🇳Shanghai, China
University of KwaZulu-Natal
🇿🇦Durban, KwaZulu-Natal, South Africa
St Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
Rigshospitalet - Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
University of Thessaly
🇬🇷Volos, Greece
SAL Hospital
🇮🇳Gujarat, India
Institut Jantung Negara
🇲🇾Kuala Lampur, Malaysia
San Francisco VA Medical Center
🇺🇸San Francisco, California, United States
Durham Veterans Affairs Medical Center
🇺🇸Durham, North Carolina, United States
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
London Health Sciences Center
🇨🇦London, Ontario, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Narayana Health
🇮🇳Bangalore, Karnataka, India
Kelowna General Hospital
🇨🇦Kelowna, British Columbia, Canada
SMBD Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
Sheba Medical Center
🇮🇱Ramat Gan, Israel
University Hospital Basel
🇨🇭Basel, Switzerland
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
QEII Health Science Centre
🇨🇦Halifax, Nova Scotia, Canada
Health Sciences Centre (Memorial University)
🇨🇦St John's, Newfoundland and Labrador, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
🇨🇦Chemin Sainte-Foy, Quebec, Canada
Hospital De San Jose
🇨🇴Bogota, Colombia
Tanta University Hospital
🇪🇬Tanta, Egypt
Maine Medical Center
🇺🇸Portland, Maine, United States
Centre hospitalier de l'Université de Montréal
🇨🇦Montreal, Quebec, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Instituto del Corazón de Bucaramanga
🇨🇴Bucaramanga, Santander, Colombia
Clinica de Marly
🇨🇴Bogota, Colombia
Tel Aviv Sourasky Medical Centre
🇮🇱Tel Aviv, Israel
Cabrini Health
🇦🇺Malvern, Victoria, Australia
Barwon Health (University Hospital Geelong)
🇦🇺Melbourne, Victoria, Australia
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Montefiore Medical Center
🇺🇸Bronx, New York, United States