All patients were candidates for cardiac surgery intervention in extracorporeal circulation MedDRA version: 9.1 Level: SOC Classification code 10007541
Conditions
Interventions
Trade Name: SOLUMEDROL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methylprednisolone
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutic
Sponsors
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients candidates for cardiac surgery intervention in extracorporeal circulation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=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 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%).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: 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).;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 (a), 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. | — |
Countries
Italy
Outcome results
None listed