E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects undergoing elective cardiac surgery with Cardio Pulmonar Bypass (CPB) having baseline levels of ATIII activity equal to or higher than 60% and below 100% under all circumstances. |
|
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 | 10057461 |
E.1.2 | Term | Cardiac procedure complication |
|
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 compare postoperative ATIII levels at the ICU admission between two groups of subjects randomly allocated to receive (treatment group) or not to receive (control group) ATIII supplementation preoperatively |
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E.2.2 | Secondary objectives of the trial |
To compare heparin resistance rate between treatment and control groups. To compare the following postoperative outcomes between treatment and control groups: - Blood loss in the first 12h. - Need for blood products. - Low cardiac output syndrome. - Myocardial infarction. - Mechanical ventilation duration. - In-hospital postoperative mortality. - Thromboembolic events. - Need for surgical re-exploration resulting from bleeding. - Adverse neurological outcome. - ICU stay duration. - Prolonged ICU stay (>7 days). - Length of hospital stay |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female 2. At least 18 years of age 3. Subject needs elective cardiac surgery with cardiopulmonary bypass except for heart transplantation. 4. Subject has a baseline ATIII level of less than 100% and equal to or above 60%. 5. HIV, HBV, HCV, HAV and PARVO B19 status known prior to entry. 6. Subject has read the patient information and consent form and has agreed to participate in the trial and signed the consent sheet. 7. Subject is willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study. |
|
E.4 | Principal exclusion criteria |
1. Documented congenital ATIII deficiency or ATIII levels below 60%. 2. Subject has a baseline ATIII level of 100% or higher. 3. Subject needs emergency (non-elective) surgery. 4. Subject needs heart transplantation. 5. History of anaphylactic reaction(s) to blood or blood components. 6. Allergies to excipients. 7. Subject is pregnant. 8. Subject has any medical condition that according to the investigators judgment worsens the surgical outcome above the expected. 9. Subject has any medical condition which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment. 10. Subject has participated in any other investigational study within the last 3 months prior to inclusion. |
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E.5 End points |
E.5.1 | Primary end point(s) |
ATIII levels (average) at the ICU admission in both treatment and control groups Percentage of subjects with ATIII levels of 58% or higher at the ICU admission in both treatment and control groups. |
|
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 | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
ultimo follow-up Visit dell`ultimo paziente arruolato |
|
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 | 12 |
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 | 12 |