Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Phase 2

Completed

Conditions: Acquired Antithrombin III Deficiency
Coronary Artery Bypass

Interventions: Drug: Antithrombin III

Registration Number: NCT00823082

Lead Sponsor: Instituto Grifols, S.A.

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 levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antithrombin III treatment group	Antithrombin III	Preoperative ATIII supplementation administered immediately after anesthesia induction

Primary Outcome Measures

Name	Time	Method
Postoperative ATIII Levels at the ICU Admission	ICU admission	Measurement of postoperative ATIII functional activity at ICU admission
Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission	ICU admission	Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Postoperative Myocardial Infarction	During ICU stay (maximum 70 days)	Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram
Percentage of Subjects With Adverse Neurologic Outcome	During ICU stay (maximum 70 days)	Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting \>12 hours after extubation
Percentage of Patients With Thromboembolic Events	During ICU stay (maximum 70 days)	Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism
ICU Stay Duration	During ICU stay (maximum 70 days)
In-hospital Postoperative Mortality	70 days after ICU admission (maximum)
Heparin Resistance	Immediately after anesthesia induction	Percentage of subjects with heparin resistance defined as failure to reach an activated clotting time \>450 seconds after a dose of up to 400 IU/kg of heparin, or failure to maintain this activated clotting time value despite heparin supplementations of 100 IU/kg per each dose with an interval of at least 30 minutes between doses
Postoperative Blood Loss in First 12 Hours	ICU admission through 12 hours post-operative	Blood loss defined as the amount of blood collected in the cardiotomy reservoir from ICU admission through the following 12 hours
Need for Blood Products	During ICU stay (maximum 70 days)	Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed
Percentage of Subjects Needing Surgical Re-exploration	During ICU stay (maximum 70 days)	Percentage of subjects needing surgical re-exploration resulting from bleeding
Percentage of Subjects With Low Cardiac Syndrome	During ICU stay (maximum 70 days)	Percentage of subjects with low cardiac syndrome defined as the need for major inotropic support or intra-aortic balloon pump
Percentage of Subjects With Renal Dysfunction	During ICU stay (maximum 70 days)	Percentage of subjects with renal dysfunction defined as an increase of serum creatinine levels to \>2.0 and twice the baseline level or need for renal replacement therapy
Mechanical Ventilation Duration	During ICU stay (maximum 70 days)
Length of Hospital Stay	During ICU stay (maximum 70 days)	Length of hospital stay (days) in both groups was defined as the discharge date minus the surgery date plus 1 day, during a maximum of 70 days after ICU admission.