Patients candidates for cardiac surgery intervention in extracorporeal circulation MedDRA version: 9.1 Level: SOC Classification code 10007541
Conditions
Interventions
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Antithrombin III
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 1000-
Sponsors
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients candidates for cardiac surgery intervention in extracorporeal circulation with levels of antithrombin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 180 minutes 14) Subjects incapable of giving legal consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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 (a), 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 | — |
Countries
Italy
Outcome results
None listed