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

Acute Coronary Syndrome Clinical Trial

— ATIII  

Official title:

Effects of the Administration Of Antithrombin on the Coagulation Status and on the Inflammatory Response in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01201070
• Other study ID #: Antithrombin III
• Status: Unknown status
• Phase: Phase 4
• First received: September 8, 2010
• Last updated: September 14, 2010
• Start date: September 2009
• Est. completion date: November 2011

Study information

• Verified date: July 2010
• Source: University of Bari
• Contact: Domenico Paparella, MD
• Phone: +39 080 559 5075
• Email: dpaparella[@]cardiochir.uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 90
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic
• Mitral Valve Insufficiency
• Mitral Valve Stenosis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Policlinico	Bari

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with infection as a measure of safety.		until 5 days after surgery
Secondary	Number of participants with delirium as a measure of safety.		until 5 days after surgery
Secondary	Number of participants with wound complication as a measure of safety.		until 5 days after surgery
Secondary	Number of participants with multi organ failure as a measure of safety.		until 5 days after surgery