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 | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030860 |
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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 demonstrate efficacy and safety of TachoSil in cardiovascular surgery. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
All inclusion criteria must be answered yes for a subject to participate in the trial. At Screening 1.Has the subject given informed consent according to local requirements before any trial related activities A trial related activity is any procedure that would not have been performed during the routine management of the subject. In this trial the screening is the first trial related activity. 2.For female subjects of childbearing potential Is the pregnancy test at screening negative 3.Does the female subject of child-bearing potential use adequate contraception contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device 4.Is the subject major or equal 18 years of age 5.Is the following planned An elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure Intra operative after primary haemostatic treatment 6.Is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present 7.Has the area with the most problematic haemorrhage target area been identified please note that this must be done before randomisation . 8.Is it possible to compress the randomised treatment TachoSil or control fleece material for 3 minutes |
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E.4 | Principal exclusion criteria |
All exclusion criteria must be answered no for a subject to participate in the trial. At Screening 1.Has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial 2.Does the subject participate in a clinical trial concomitantly with the present trial 3.Is the subject undergoing an emergency operation 4.Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin 5.Is the subject suffering from known coagulopathy 6.Is the subject currently participating or has the subject previously participated in the TC-023-IM trial 7.Is the female subject pregnant or breast feeding Intra operative after primary haemostatic treatment 8.Has liquid fibrin sealant/glue or TachoSil been applied 9.Has the following occurred Disseminated intravascula |
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E.5 End points |
E.5.1 | Primary end point(s) |
Propotion of patients achieving haemostasis after 3 minuts. |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
contronto con la terapia emostatica standard |
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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.8.5 | 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 | 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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |