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

Information source: University of Bari
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aortic Valve Insufficiency; Aortic Valve Stenosis; Mitral Valve Insufficiency; Mitral Valve Stenosis; Acute Coronary Syndrome

Intervention: antithrombin III (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Bari

Official(s) and/or principal investigator(s):
Domenico Paparella, Investigator, Principal Investigator, Affiliation: Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy

Overall contact:
Domenico Paparella, MD, Phone: +39 080 559 5075, Email: dpaparella@cardiochir.uniba.it

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

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.

Number of participants with delirium as a measure of safety.

Number of participants with wound complication as a measure of safety.

Number of participants with multi organ failure as a measure of safety.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Domenico Paparella, MD, Phone: +39 080 559 5075, Email: dpaparella@cardiochir.uniba.it

Azienda Ospedaliero-Universitaria Policlinico, Bari 70124, Italy; Recruiting
Paparella, MD, Email: dpaparella@cardiochir.uniba.it
Crescenzia Rotunno, BSc, Sub-Investigator
Additional Information

Starting date: September 2009
Last updated: September 14, 2010

Page last updated: February 07, 2013

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