E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048935 |
E.1.2 | Term | Open heart surgery |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.)
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E.4 | Principal 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)
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
same drug with different dose |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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end of the recrutement period |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 12 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |