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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | ||
| no treatment | No Intervention | ||
| TREATMENT WITH ANTITHROMBIN | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antithrombin III | Drug | 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 |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenico Paparella, MD | Contact | +39 080 559 5075 | dpaparella@cardiochir.uniba.it |
| Name | Affiliation | Role |
|---|---|---|
| Domenico Paparella, Investigator | Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Policlinico | Recruiting | Bari | 70124 | Italy |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 30, 2017 | |
| Reset | Aug 10, 2018 |
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| 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 30, 2017 | Aug 10, 2018 |
| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| D001024 | Aortic Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| D008946 | Mitral Valve Stenosis |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000990 | Antithrombin III |
| ID | Term |
|---|---|
| D058833 | Antithrombin Proteins |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000510 | Alpha-Globulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D005916 | Globulins |
| D019774 | Blood Coagulation Factor Inhibitors |
| D001685 | Biological Factors |
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