A Prospective Randomized Pilot Study to Evaluate the Effect of Preoperative Antithrombin Supplementation on Postoperative Levels of Antithrombin in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Instituto Grifols, S.A.1 site in 1 country200 target enrollmentJune 2009

ConditionsAcquired Antithrombin III Deficiency Coronary Artery Bypass

InterventionsAntithrombin III

DrugsAntithrombin III

Overview

Phase: Phase 2
Intervention: Antithrombin III
Conditions: Acquired Antithrombin III Deficiency
Sponsor: Instituto Grifols, S.A.
Enrollment: 200
Locations: 1
Primary Endpoint: Postoperative ATIII Levels at the ICU Admission
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

September 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Instituto Grifols, S.A.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Antithrombin III treatment group

Preoperative ATIII supplementation administered immediately after anesthesia induction

Intervention: Antithrombin III

Outcomes

Primary Outcomes

Postoperative ATIII Levels at the ICU Admission

Time Frame: ICU admission

Measurement of postoperative ATIII functional activity at ICU admission

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

Time Frame: ICU admission

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

Secondary Outcomes

Percentage of Subjects With Postoperative Myocardial Infarction(During ICU stay (maximum 70 days))
Percentage of Subjects With Adverse Neurologic Outcome(During ICU stay (maximum 70 days))
Percentage of Patients With Thromboembolic Events(During ICU stay (maximum 70 days))
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)
Postoperative Blood Loss in First 12 Hours(ICU admission through 12 hours post-operative)
Need for Blood Products(During ICU stay (maximum 70 days))
Percentage of Subjects Needing Surgical Re-exploration(During ICU stay (maximum 70 days))
Percentage of Subjects With Low Cardiac Syndrome(During ICU stay (maximum 70 days))
Percentage of Subjects With Renal Dysfunction(During ICU stay (maximum 70 days))
Mechanical Ventilation Duration(During ICU stay (maximum 70 days))
Length of Hospital Stay(During ICU stay (maximum 70 days))