Transfusion Requirements in Cardiac Surgery III

Disorder; Heart, Functional, Postoperative, Cardiac Surgery Clinical Trial

— TRICS-III  

Official title:

An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042898
• Other study ID #: TRICSIII
• Secondary ID: 301852
• Status: Completed
• Phase: N/A
• Start date: January 20, 2014
• Est. completion date: October 1, 2017

Study information

• Verified date: August 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5028
• Est. completion date: October 1, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Intervention

Other:
• Restrictive Transfusion Strategy

• Liberal transfusion strategy

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St Vincent's Hospital, Melbourne	Fitzroy	Victoria
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Cabrini Health	Malvern	Victoria
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Barwon Health (University Hospital Geelong)	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Brazil	Hospital Unimed Rio (National Institute of Cardiology)	Rio de Janeiro
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Chemin Sainte-Foy	Quebec
Canada	University of Alberta	Edmonton	Alberta
Canada	QEII Health Science Centre	Halifax	Nova Scotia
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Kelowna General Hospital	Kelowna	British Columbia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Center	London	Ontario
Canada	Centre hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	Hôpital du Sacré-Cœur de Montréal	Montreal	Quebec
Canada	SMBD Jewish General Hospital	Montreal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Health Sciences Centre (Memorial University)	St John's	Newfoundland and Labrador
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network Toronto General Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	St Boniface Hospital	Winnipeg	Manitoba
China	Renji Hospital	Shanghai
China	Shanghai Yodak Cardio-Thoracic Hospital	Shanghai
Colombia	Clinica de Marly	Bogota
Colombia	Fundacion Cardioinfantil Instituto de Cardiologia	Bogota
Colombia	Fundación Clínica Shaio	Bogota
Colombia	Hospital De San Jose	Bogota
Colombia	Instituto del Corazón de Bucaramanga	Bucaramanga	Santander
Denmark	Rigshospitalet - Copenhagen University Hospital	Copenhagen
Egypt	Tanta University Hospital	Tanta
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	University Hospital Giessen	Giessen
Greece	University of Thessaly	Volos
India	Narayana Health	Bangalore	Karnataka
India	SAL Hospital	Gujarat
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Centre	Tel Aviv
Malaysia	Institut Jantung Negara	Kuala Lampur
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Hospital	Wellington
Romania	Emergency Institute for Cardiovascular Diseases	Târgu-Mure?
Singapore	National Heart Centre Singapore	Singapore
South Africa	University of KwaZulu-Natal	Durban	KwaZulu-Natal
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Ramón y Cajal	Madrid
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Instituto de Investigación Sanitaria Hospital Univ. & Politc. La Fe de Valencia	Valencia
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Bern (Inselspital)	Bern
United States	Montefiore Medical Center	Bronx	New York
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Durham Veterans Affairs Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Michael E. DeBakey Veterans Affairs Medical Center	Houston	Texas
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Maine Medical Center	Portland	Maine
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  Colombia,  Denmark,  Egypt,  Germany,  Greece,  India,  Israel,  Malaysia,  New Zealand,  Romania,  Singapore,  South Africa,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Incidence of in-hospital all-cause mortality		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Incidence of in-hospital myocardial infarction		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Incidence of in-hospital new renal failure requiring dialysis		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Incidence of in-hospital new focal neurological deficit		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Length of stay in the ICU and hospital		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	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)
Secondary	Duration of mechanical ventilation		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Incidence of infection		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Incidence of gut infarction		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	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)
Secondary	Death		6 months
Secondary	New onset dialysis (since incident surgery) status		6 months
Secondary	Stroke		6 months
Secondary	Coronary revascularization		6 months
Secondary	Myocardial infarction		6 months
Secondary	Health Care Utilization		6 months
Secondary	Renal function, based on changes in postoperative serum creatinine		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Incidence of Seizures		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Incidence of Encephalopathy		Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary	Incidence of Delirium		Up to hospital discharge or postoperative day 28 (whichever occurs first)