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

University of Bari

Status and phase: Unknown; Phase 4

Conditions: Mitral Valve Insufficiency; Aortic Valve Stenosis; Acute Coronary Syndrome; Mitral Valve Stenosis; Aortic Valve Insufficiency

Treatments: Drug: antithrombin III

Study type: Interventional

Funder types: Other

Identifiers

NCT01201070

Antithrombin III

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

control group

No Intervention group

no treatment

No Intervention group

TREATMENT WITH ANTITHROMBIN

Active Comparator group

Description:

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

Treatment:

Drug: antithrombin III