Cardiac Surgery Clinical Trial
Official title:
A Prospective Study of Coronary Artery Bypass Graft and/or Aortic Valve Replacement With Conventional Versus Half Heparin Dose Under Closed and Coated Extra Corporeal Circulation System (MECC) - APPACHES Study.
The purpose of this study is to demonstrate superiority on postoperative bleeding from the use of a heparin half dose compared to a conventional dose, under mini-extra corporeal circulation, without increased risk to the patient.
Usually management of conventional extra corporeal circulation takes place under a loading
heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than
400 seconds. This empirical approach based on patient weight date from the 1960's and does
not take into account materials improvement and different individual sensitivities; several
studies have demonstrated than a result at least as effective could be obtained with heparin
lower doses, and without increasing thromboembolic morbid events for patients.
Patients are randomly assigned into one of 2 groups one day before surgery. First group
receive unfractionated heparin conventional dose during the MECC, second group receive half
of the conventional dose. All surgery is performed by the same team and using same
equipment. Regular blood tests are carried out before, during and after surgery. Blood loss,
transfusion needs, rhythm disorders, stay duration in intensive care and total
hospitalization length is finally reported. The follow-up period through the 30th
postoperative day.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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