Transfusion Requirements in Cardiac Surgery III

Not Applicable

Completed

• Conditions: Disorder; Heart, Functional, Postoperative, Cardiac Surgery

• 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

Study Timeline

• Study First Submitted: 2014-01-17
• Study Start: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Primary Completion: 2017-04-28
• Study Completion: 2017-10-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5028

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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 all-cause mortality	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)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Durham Veterans Affairs Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Michael E. DeBakey Veterans Affairs Medical Center; 🇺🇸 Houston, Texas, United States

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 Sydney, New South Wales, Australia

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