Brief Title
Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
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
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).
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.
Secondary Outcome
Number of participants with infection as a measure of safety.
Condition
Aortic Valve Insufficiency
Intervention
antithrombin III
Study Arms / Comparison Groups
control group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
90
Start Date
September 2009
Completion Date
November 2011
Primary Completion Date
November 2011
Eligibility Criteria
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Domenico Paparella, Investigator, +39 080 559 5075, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01201070
Organization ID
Antithrombin III
Study Sponsor
University of Bari
Study Sponsor
Domenico Paparella, Investigator, Principal Investigator, Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy
Verification Date
July 2010