EFFECTS OF PREVENTIVE TREATMENT WITH STEROIDS ON COAGULATION DYSFUNCTION INDUCED BY EXTRACORPOREAL CIRCULATION - ND

• Conditions: All patients were candidates for cardiac surgery intervention in extracorporeal circulation; MedDRA version: 9.1Level: SOCClassification code 10007541

• Registration Number: EUCTR2010-020329-42-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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%).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified