Subjects undergoing elective cardiac surgery with Cardio Pulmonar Bypass (CPB) having baseline levels of ATIII activity equal to or higher than 60% and below 100% under all circumstances. MedDRA version: 9.1 Level: LLT Classification code 10057461 Term: Cardiac procedure complication
Conditions
Interventions
Trade Name: ANBINEX
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Antithrombin III
Concentration unit: IU international unit(s)
Concentration type: equal
Conce
Sponsors
GRIFOLS ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. At least 18 years of age 3. Subject needs elective cardiac surgery with cardiopulmonary bypass except for heart transplantation. 4. Subject has a baseline ATIII level of less than 100% and equal to or above 60%. 5. HIV, HBV, HCV, HAV and PARVO B19 status known prior to entry. 6. Subject has read the patient information and consent form and has agreed to participate in the trial and signed the consent sheet. 7. Subject is willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Documented congenital ATIII deficiency or ATIII levels below 60%. 2. Subject has a baseline ATIII level of 100% or higher. 3. Subject needs emergency (non-elective) surgery. 4. Subject needs heart transplantation. 5. History of anaphylactic reaction(s) to blood or blood components. 6. Allergies to excipients. 7. Subject is pregnant. 8. Subject has any medical condition that according to the investigators judgment worsens the surgical outcome above the expected. 9. Subject has 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. 10. Subject has participated in any other investigational study within the last 3 months prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare postoperative ATIII levels at the ICU admission between two groups of subjects randomly allocated to receive (treatment group) or not to receive (control group) ATIII supplementation preoperatively;Secondary Objective: To compare heparin resistance rate between treatment and control groups. To compare the following postoperative outcomes between treatment and control groups: - Blood loss in the first 12h. - Need for blood products. - Low cardiac output syndrome. - Myocardial infarction. - Mechanical ventilation duration. - In-hospital postoperative mortality. - Thromboembolic events. - Need for surgical re-exploration resulting from bleeding. - Adverse neurological outcome. - ICU stay duration. - Prolonged ICU stay (>7 days). - Length of hospital stay;Primary end point(s): ATIII levels (average) at the ICU admission in both treatment and control groups Percentage of subjects with ATIII levels of 58% or higher at the ICU admission in both treatment and control groups. | — |
Countries
Italy
Outcome results
None listed