Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery

Phase 4

• Conditions: Mitral Valve Stenosis; Aortic Valve Insufficiency; Aortic Valve Stenosis; Mitral Valve Insufficiency; Acute Coronary Syndrome
• Interventions: Drug: antithrombin III

• Registration Number: NCT01201070
• Lead Sponsor: University of Bari

Brief Summary

General and specific objectives of the search: evaluate the effects of the administration of Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response and markers of organ damage in patients undergoing cardiac surgery by cardiopulmonary bypass (CPB) with low plasma levels of post-operative Antithrombin (AT).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-07
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Last Update Submitted: 2010-09-14
• Last Update Posted: 2010-09-15
• Primary Completion: 2011-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All patients were candidates for cardiac surgery intervention in extracorporeal circulation

Exclusion Criteria

• positive history for allergic reactions to AT III
• cardiac surgery "Off-Pump"
• administration of AT during surgery or within 48 h
• treatment with drugs and non-steroidal steroids within 48 h prior
• disorders of coagulation
• platelets <30,000
• pre-existing IRC in dialysis treatment
• severe liver failure
• enlistment in another trial in the last 30 days
• hypothermia
• emergency
• reopening
• length of CEC> 180 minutes
• subjects incapable of giving legal consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TREATMENT WITH ANTITHROMBIN	antithrombin III	3000 IU bolus at the time of randomization vs the study group 1000 IU after 8 h (24 h G0) 1000 IU after 16 h (8 h G1) TOTAL 5000/UI 24h

Primary Outcome Measures

Name	Time	Method
Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.	until 5 days after surgey

Secondary Outcome Measures

Name	Time	Method
Number of participants with infection as a measure of safety.	until 5 days after surgery
Number of participants with delirium as a measure of safety.	until 5 days after surgery
Number of participants with wound complication as a measure of safety.	until 5 days after surgery
Number of participants with multi organ failure as a measure of safety.	until 5 days after surgery

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Policlinico; 🇮🇹 Bari, Italy