Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acquired Antithrombin III Deficiency Coronary Artery Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Antithrombin III treatment group

Preoperative ATIII supplementation administered immediately after anesthesia induction

Group Type EXPERIMENTAL

Antithrombin III

Intervention Type DRUG

Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

Control group

No preoperative ATIII supplementation administered

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antithrombin III

Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

Intervention Type DRUG

Other Intervention Names

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Anbinex ATIII

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No