E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
All patients were 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 |
to assess the effect of prophylaxis with anti-inflammatory steroids on coagulation function on fibrinolysis, platelet function, blood loss and postoperative incidence of blood transfusions and blood products in patients undergoing intervention cardiac surgery by means of extracorporeal circulation (CEC). |
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E.2.2 | Secondary objectives of the trial |
to assess the effect of prophylaxis with anti-inflammatory steroids on coagulation function on fibrinolysis, platelet function, blood loss and postoperative incidence of blood transfusions and blood products in patients undergoing intervention cardiac surgery by means of extracorporeal circulation (CEC). |
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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 |
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E.4 | Principal exclusion criteria |
1) positive history for allergic reactions to cortisone 2) Age greater than 80 years 3) Infections preoperative history of recent infection, clinical signs of infection, T> 37.5 � C or WBC> 12000/μl. 4) History of cancer or autoimmune diseases 5) Treatment with corticosteroid drugs or preoperative immuno-suppressors. 6) preoperative oral anticoagulant therapy (preoperative 48 hours). 7) Diabetes. 8) Emergency surgery (interval between admission and intervention less than 6 hours). 9) Aortic counterpulsation. 10) Combined intervention. 11) Anemic state preoperative (Hematocrit <30%). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical parameters Will assess the blood loss, blood transfusions and blood products. Laboratory parameters: Activation of the coagulation system. Will be measured the levels of AT, PT, aPTT and fibrinogen (FBG). Activation of the coagulation system will be assessed by measuring the formation of thrombin, in particular, the plasma levels of prothrombin fragment 1-2 (PF-1.2), using ELISA kits commercially available. Platelet activation. The activation and platelet function will be measured: i) indirectly as a drop in platelet counts, ie platelet consumption, release of platelet factor 4 (PF-4) in plasma. ii) directly from the analysis of platelet function (PFA 100). System activation of fibrinolysis. The activation of the fibrinolysis system will be assessed by measuring plasma levels of PAP and degradation products of fibrin (D-dimers). Thromboelastogram. Reaction time (R), Alpha angle (α), Maximum ampitude (MA), Lysis index 30 (LY30). Inflammatory parameters. The activation of inflammation will be assessed by measuring the levels of IL-6, FBG, PCR and WBC. Parameters of organ damage. Will measure the 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 | Yes |
E.6.3 | Therapy | No |
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 | Yes |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
| |
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 |