EFFECTS OF THE ADMINISTRATION OF ANTITHROMBIN ON THE EMOCOAGULATIVE STATE AND ON THE INFLAMMATORY RESPONSE IN PATIENT WITH LOW PLASMATIC LEVELS OF ANTITHROMBIN AFTER CARDIAC INTERVENTIONS - ND

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

• Registration Number: EUCTR2010-020377-16-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-06
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients candidates for cardiac surgery intervention in extracorporeal circulation with levels of antithrombin < 65%
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 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

Study & Design

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