E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients candidates for cardiac surgery intervention in extracorporeal circulation |
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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 | SOC |
E.1.2 | Classification code | 10007541 |
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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 |
evaluate the effects of the administration of AT on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response and markers of organ damage in patients undergoing cardiac interventions by extracorporeal circulation (ECC) with low plasma levels of post-operative AT. |
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E.2.2 | Secondary objectives of the trial |
evaluate the effects of the administration of AT on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response and markers of organ damage in patients undergoing cardiac interventions by extracorporeal circulation (ECC) with low plasma levels of post-operative AT. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients candidates for cardiac surgery intervention in extracorporeal circulation with levels of antithrombin < 65% |
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E.4 | Principal exclusion criteria |
1) positive history for allergic reactions to AT III 2) cardiac surgery ``Off-Pump`` 3) AdminIstration of AT during surgery or within 48 h earlier (the administration of AT prior to the CEC occurs in patients with resistance all`eparina - ACT <400 sec after administration of heparin 300U/Kg -. Exclusion of these patients is necessary to ensure that in the control group, or in one of two study groups, there are high values of AT preoperative administration). 4) Treatment with drugs and non-steroidal steroids within 48 h prior 5) Coagulatives disorders 6) Platelets <30,000 7) Pre-existing IRC in dialysis treatment 8) Severe liver failure 9) Enlistment in another trial in the last 30 days 10) Spoke in deep hypothermia 11) Interventions in Emergency 12) Reintervention 13) Length of CEC> 180 minutes 14) Subjects incapable of giving legal consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
Blood loss, blood transfusions and blood products. Complications of post-operative body. Laboratory parameters: activation of the coagulation system (levels of AT, PT, aPTT and fibrinogen, thrombin-antithrombin complex).Platelet activation (indirectly as a drop in platelet counts, ie platelet consumption, directly as a direct release of platelet factor 4 (PF-4) in plasma. System activation of fibrinolysis ( levels of t-PA, PAI-1 and degradation products of fibrin (D-dimers). Thromboelastogram. Reaction time (R), Alpha angle (α), Maximum ampitude (MA), Lysis index 30 (LY30). Inflammatory parameters (levels of IL-6, TNF-alpha e PCR). Parameters of organ damage (levels of cardiac Troponin I (cTnI), as index of myocardial injury, levels of creatinine as index of renal damage and levels of bilirubin, GOT and GPT as indices of liver injury |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | 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 |
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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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |