Clinical trial NCT00823082: Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Antithrombin III Deficiency
Coronary Artery Bypass
Keywords: antithrombin
ATIII
acquired deficiency
anticoagulants
cardiopulmonary bypass
surgery
complications
postoperative outcomes
Lead sponsor: Grifols Biologicals, LLC
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Postoperative ATIII Levels at the ICU Admission
timeFrame: ICU admission
measure: Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission
timeFrame: ICU admission
Secondary outcomes:
measure: Percentage of Subjects With Postoperative Myocardial Infarction
timeFrame: During ICU stay (maximum 70 days)
measure: Percentage of Subjects With Adverse Neurologic Outcome
timeFrame: During ICU stay (maximum 70 days)
measure: Percentage of Patients With Thromboembolic Events
timeFrame: During ICU stay (maximum 70 days)
measure: ICU Stay Duration
timeFrame: During ICU stay (maximum 70 days)
measure: In-hospital Postoperative Mortality
timeFrame: 70 days after ICU admission (maximum)
measure: Heparin Resistance
timeFrame: Immediately after anesthesia induction
measure: Postoperative Blood Loss in First 12 Hours
timeFrame: ICU admission through 12 hours post-operative
measure: Need for Blood Products
timeFrame: During ICU stay (maximum 70 days)
measure: Percentage of Subjects Needing Surgical Re-exploration
timeFrame: During ICU stay (maximum 70 days)
measure: Percentage of Subjects With Low Cardiac Syndrome
timeFrame: During ICU stay (maximum 70 days)
measure: Percentage of Subjects With Renal Dysfunction
timeFrame: During ICU stay (maximum 70 days)
measure: Mechanical Ventilation Duration
timeFrame: During ICU stay (maximum 70 days)
measure: Length of Hospital Stay
timeFrame: During ICU stay (maximum 70 days)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Policlinico San Donato
state: Lombardy
Study officials:
affiliation: IRCCS Policlinico San Donato, Milano
name: Marco Ranucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranucci M, Baryshnikova E, Crapelli GB, Woodward MK, Paez A, Pelissero G. Preoperative antithrombin supplementation in cardiac surgery: a randomized controlled trial. J Thorac Cardiovasc Surg. 2013 May;145(5):1393-9. doi: 10.1016/j.jtcvs.2012.09.061. Epub 2012 Oct 25.