Status:
COMPLETED
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
Lead Sponsor:
Instituto Grifols, S.A.
Conditions:
Acquired Antithrombin III Deficiency
Coronary Artery Bypass
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 leve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00823082
Start Date
June 1 2009
End Date
September 1 2011
Last Update
September 20 2016
Active Locations (1)
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1
IRCCS Policlinico San Donato
Milan, Lombardy, Italy, 20097