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

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

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 Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis; Mitral Valve Insufficiency; Aortic Valve Insufficiency; Acute Coronary Syndrome; Mitral Valve Stenosis
• Intervention / Treatment: Drug: antithrombin III

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Domenico Paparella, MD; Phone Number: +39 080 559 5075; Email: dpaparella@cardiochir.uniba.it

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
No Intervention: no treatment
Active Comparator: TREATMENT WITH ANTITHROMBIN; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Bari
• Investigators: Principal Investigator: Domenico Paparella, Investigator, Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: September 8, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Estimate): September 15, 2010
• Last Update Submitted That Met QC Criteria: September 14, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Mitral Valve Insufficiency; Aortic Valve Insufficiency; Constriction, Pathologic; Acute Coronary Syndrome; Mitral Valve Stenosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Anticoagulants; Antithrombins; Antithrombin III
• Other Study ID Numbers: Antithrombin III