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

Sponsor

University of Bari (Other)

Overall Status

Unknown status

CT.gov ID

NCT01201070

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Insufficiency Aortic Valve Stenosis Mitral Valve Insufficiency Mitral Valve Stenosis Acute Coronary Syndrome	Drug: antithrombin III	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

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 Start Date :

Sep 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2011

Anticipated Study Completion Date :

Nov 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliero-Universitaria Policlinico	Bari		Italy	70124

Sponsors and Collaborators

University of Bari

Investigators

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