Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00823082 | Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass | PHASE2 | COMPLETED | 200 | — | — | Jun 1, 2009 | Sep 1, 2011 | Sep 20, 2016 | 1 | Italy |
Measurement of postoperative ATIII functional activity at ICU admission
Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission
| Arm | Type | Description |
|---|---|---|
| Antithrombin III treatment group | EXPERIMENTAL | Preoperative ATIII supplementation administered immediately after anesthesia induction |
| Control group | NO_INTERVENTION | No preoperative ATIII supplementation administered |
| Name | Type | Description |
|---|---|---|
| Antithrombin III | DRUG | Single dose of antithrombin III sufficient to achieve a preoperative level of 120% |
Inclusion Criteria: * Male or female * At least 18 years of age * Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation * Subject had a baseline ATIII level of less than 100% and equal to or above 60% * Subject signed the informed consent form * Subjec...