Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Grifols

Status and phase

Completed

Phase 2

Conditions

Acquired Antithrombin III Deficiency

Coronary Artery Bypass

Treatments

Drug: Antithrombin III

Study type

Interventional

Funder types

Industry

Identifiers

NCT00823082

IG0801

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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