Transfusion Requirements in Cardiac Surgery III

Study Overview
=================
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.

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

Conditions
-----------------
Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Intervention / Treatment
-----------------
* Other: Restrictive Transfusion Strategy
* Other: Liberal transfusion strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restrictive transfusion strategy<br>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 | Other: Restrictive Transfusion Strategy<br> <br> |
| Active Comparator: Liberal transfusion strategy<br>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. | Other: Liberal transfusion strategy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| Death |  | 6 months | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Surgery, Transfusion