cardiac surgery MedDRA version: 9.1 Level: LLT Classification code 10048935 Term: Open heart surgery
Conditions
Interventions
Trade Name: Exacyl
Product Name: Exacyl
Pharmaceutical Form: Solution for injection
Sponsors
Hopital Foch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be recruited from 3 french cardiac surgical programs. We will enroll all cardiac surgical patients who require one of the following no urgent surgical initial or re-operation interventions. A urine pregancy test will be needed in all women with childbearing potential before inclusion. • coronary artery bypass graft • single or multiple valve replacement • single or multiple valve replacement with a coronary artery bypass • ascending aortic artery procedures (including Bental procedures, etc.) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients excluded will be: • patients less than 18years of age • pregnant woman • patients who refuse consent (refusal from patient or physician) • patients with history of previous antifibrinolytic or thrombolytic therapy within 5 days of surgery • patients currently enrolled in another perioperative interventional study • Jehovah’s Witnesses • patients with allergic to exacyl, with history of arterial or venous thrombotic event or seizure • have a thrombocytopenia defined as a ; • patients with a coagulopathy defined as an INR > 2, PT < 50% or a platelet count <50,000/mm3 prior to surgery • patients with hepathopathy Child-Pugh B or C • severe chronic renal failure (defined as a creatinine clearance < 30 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of this trial are:allogeneic exposure to any blood product; requirement of reoperation for hemorrhage; total bleeding within the first 24 hours; • 7 and 28-day all-cause mortality ;Primary end point(s): The primary end point of this trial is the percent of patients who receive allogenic blood product within 7 days after suregery.;Main Objective: The main objective of this trial is to compare the effect of two different dose of Exacyl on the need for transfusion in patients undergoing cardiac surgery with cardioplumonary bypass. - Low dose group: Exacyl will be administered as a 10mg/kg bolus after induction and prior to skin incision followed by 1mg/kg infused into the bypass pump circuit and 1mg/kg/hr thereafter. -High dose group: Exacyl will be administered as a 30mg/kg bolus after induction and prior to skin incision followed by 16mg/kg infused into the bypass pump circuit and 2mg/kg/hr thereafter. | — |
Countries
France
Outcome results
None listed