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

Phase 4UnknownNCT01201070

University of Bari90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Aortic Valve Insufficiency Aortic Valve Stenosis Mitral Valve Insufficiency Mitral Valve Stenosis Acute Coronary Syndrome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.

Time frame: until 5 days after surgey

Secondary Outcomes

Number of participants with infection as a measure of safety.

Time frame: until 5 days after surgery

Number of participants with delirium as a measure of safety.

Time frame: until 5 days after surgery

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

Time frame: until 5 days after surgery

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

Time frame: until 5 days after surgery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts