Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis, Acute Coronary Syndrome
Conditions
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).
Interventions
DRUGantithrombin 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
Sponsors
University of Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
Italy
Contacts
Primary ContactDomenico Paparella, MD
Outcome results
None listed