Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Instituto Grifols, S.A.200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

Acquired Antithrombin III Deficiency Coronary Artery Bypass

Interventions

Antithrombin IIIDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IRCCS Policlinico San Donato

Milan, Lombardy, Italy

Outcomes

Primary Outcomes

Postoperative ATIII Levels at the ICU Admission

Measurement of postoperative ATIII functional activity at ICU admission

Time frame: ICU admission

Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission

Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission

Time frame: ICU admission

Secondary Outcomes

Percentage of Subjects With Postoperative Myocardial Infarction

Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram

Time frame: During ICU stay (maximum 70 days)

Percentage of Subjects With Adverse Neurologic Outcome

Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting \>12 hours after extubation

Time frame: During ICU stay (maximum 70 days)

Percentage of Patients With Thromboembolic Events

Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism

Time frame: During ICU stay (maximum 70 days)

ICU Stay Duration

Time frame: During ICU stay (maximum 70 days)

In-hospital Postoperative Mortality

Time frame: 70 days after ICU admission (maximum)

Heparin Resistance

Data from ClinicalTrials.gov

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