Phase 2
Completed N=200
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
Acquired Antithrombin III Deficiency · Coronary Artery Bypass
Source: ClinicalTrials.gov NCT00823082 ↗
Enrolled (actual)
200
Serious AEs
30.7%
Results posted
Aug 2016
Primary outcomePrimary: Postoperative ATIII Levels at the ICU Admission — 94.06; 64.70 IU — p=<0.0001
Summary
The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative ATIII Levels at the ICU Admission |
94.06; 64.70 | <0.0001 sig |
| PRIMARY Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission |
100.0; 74.5 | <0.0001 sig |
| SECONDARY Percentage of Subjects With Postoperative Myocardial Infarction |
0.0; 0.0; 1.0; 2.2 | 0.6115 |
| SECONDARY Percentage of Subjects With Adverse Neurologic Outcome |
5.3; 0.0; 1.0; 0.0 | 0.1211 |
| SECONDARY Percentage of Patients With Thromboembolic Events |
0.0; 0.0; 0.0; 1.1 | 0.4870 |
| SECONDARY ICU Stay Duration |
2.00; 2.00 | 0.3897 |
| SECONDARY In-hospital Postoperative Mortality |
1.0; 1.1 | 1.0000 |
| SECONDARY Heparin Resistance |
17.2; 40.4 | 0.0004 sig |
| SECONDARY Postoperative Blood Loss in First 12 Hours |
516.11; 415.00 | 0.0209 sig |
| SECONDARY Need for Blood Products |
43.711; 41.987; 12.188; 13.125; 8.500; 6.188 | 0.7433 |
| SECONDARY Percentage of Subjects Needing Surgical Re-exploration |
5.1; 2.2 | 0.4460 |
| SECONDARY Percentage of Subjects With Low Cardiac Syndrome |
24.7; 20.4 | 0.4936 |
| SECONDARY Percentage of Subjects With Renal Dysfunction |
1.3; 0.0; 3.0; 1.1 | 1.000 |
| SECONDARY Mechanical Ventilation Duration |
1.00; 1.00 | 0.9574 |
| SECONDARY Length of Hospital Stay |
10.00; 10.00 | 0.7489 |
Eligibility Criteria
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
- Subject was willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study
Exclusion Criteria
- Documented congenital ATIII deficiency or ATIII levels below 60%
- Subject had a baseline ATIII level of 100% or higher
- Subject needed emergency (non-elective) surgery
- Subject needed heart transplantation
- History of anaphylactic reaction(s) to blood or blood components
- Allergies to excipients
- Subject was pregnant
- Subject had any medical condition that according to the investigators judgment worsens the surgical outcome above the expected
- Subject had any medical condition which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment
- Subject had participated in any another investigational study within the last 30 days previous to the inclusion
Data sourced from ClinicalTrials.gov (NCT00823082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.