A Prospective Randomized Pilot study to evaluate the effect of preoperative antithrombin supplementation on postoperative levels of antithrombin in patients undergoing cardiac surgery with cardiopulmonary bypass. - ATIII-DAF/DI in Cardiac Surgery Protocol

Conditions: 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: 9.1Level: LLTClassification code 10057461Term: Cardiac procedure complication

Registration Number: EUCTR2008-007313-68-IT

Lead Sponsor: GRIFOLS ITALIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.