Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Grifols, S.A.
• Treatments: Antithrombin III; Antithrombins

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