Phase 2
N=200
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
Acquired Antithrombin III Deficiency · Coronary Artery Bypass
Bottom Line
View on ClinicalTrials.gov: NCT00823082 ↗Enrolled (actual)
200
Serious AEs
30.7%
Results posted
Aug 2016
Primary outcome: Primary: Postoperative ATIII Levels at the ICU Admission — 94.06; 64.70 IU — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Antithrombin III (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Instituto Grifols, S.A.
- Primary completion
- Jun 2011
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 |
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.
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.