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

Study Overview
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Brief Summary
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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).

Official Title
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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

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

Intervention / Treatment
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* Drug: antithrombin III


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br> | |
| No Intervention: no treatment<br> | |
| Active Comparator: TREATMENT WITH ANTITHROMBIN<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |