E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
heart disease/cardiac surgery |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061026 |
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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 |
To evaluate the safety of recombinant activated factor VII (rFVIIa) in the treatment of post-operative bleeding in patients following cardiac surgery requiring cardiopulmonary bypass.
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of recombinant activated factor VII (rFVIIa) in the treatment of post-operative bleeding in patients following cardiac surgery requiring cardiopulmonary bypass.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Informed consent obtained before any trial-related activities. • Age ≥ 18 years. • Subject is scheduled to undergo cardiac surgery requiring cardiopulmonary bypass. • Post-operative bleeding into drains placed in the cardio-thoracic cavity, assessed over a minimum of a 30 minutes period following completion of the 30 minutes stabilization period, defined as at least one of the following criteria: ≥ 200ml/hr in any one hour or part thereof, or ≥ 2 ml/kg/hr for 2 consecutive hours (part thereof is defined by any 30 minutes period following the 30 minutes stabilization period) • The subject does not require urgent re-operation at the time of meeting inclusion criterion No. 5, as per the investigator’s judgment. Please refer to Appendix D for a re-operation guideline. |
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E.4 | Principal exclusion criteria |
• Pregnant or breast-feeding (if applicable). •First time coronary artery bypass grafting with none or only one antiplatelet medication within 5 days of surgery*, or with normal preoperative coagulation (normal coagulation defined by INR<1.2, APTT within normal local reference range, or platelets > 150,000 10 6/L. If one or more values are outside of these values, coagulation is abnormal). *One antiplatelet medication can be replaced by low molecular weight heparin within 12 hours of start of surgery to comply with the above. • Cardiac or cardiopulmonary transplantation procedure. • Refusal to receive blood or blood products due to religious or any other reasons. • Any history of stroke and/or non-coronary thrombotic disorders (including DVT, PE). • Clinical signs consistent with non-coronary thrombotic disease. • Known congenital deficiency of Protein C, Protein S, Antithrombin and homozygous FV Leiden. •Patient having an unacceptable thrombotic risk, as per the investigator judgment. This encompasses any patient with additional coagulation related condition who, based upon the investigator’s professional judgment, would be at undue risk of thrombosis. •Current surgery including any implantable ventricular assist device requiring CPB including ECMO (extracorporal membrane oxygenation) • Current surgery including the aortic arch and/or descending thoracic aorta. • Known congenital bleeding disorders. • Administration of Activated Prothrombin Complex Concentrate (FEIBA, AUTOPLEX) during current surgery and/or any time before Just before dose. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Critical Serious Adverse Events (collected from trial product administration to Day 30): Death Acute myocardial infarction (AMI) Cerebral infarction Clinically symptomatic pulmonary embolism (PE) Other clinically symptomatic thrombotic events
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 9 |