Disorder; Heart, Functional, Postoperative, Cardiac Surgery
Conditions
Keywords
Cardiac Surgery, Transfusion
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.
Interventions
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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 in-hospital all-cause mortality | Up to hospital discharge or postoperative day 28 (whichever occurs first) |
| New onset dialysis (since incident surgery) status | 6 months |
| Stroke | 6 months |
| Coronary revascularization | 6 months |
| Myocardial infarction | 6 months |
| Health Care Utilization | 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) |
| Incidence of Delirium | Up to hospital discharge or postoperative day 28 (whichever occurs first) |
| Death | 6 months |
Countries
Australia, Brazil, Canada, China, Colombia, Denmark, Egypt, Germany, Greece, India, Israel, Malaysia, New Zealand, Romania, Singapore, South Africa, Spain, Switzerland, United States
Outcome results
None listed