Coronary Bypass and Artotic Leaflet Surgery : Heparin Low Dose vs Full Dose (APPACHES)
|ClinicalTrials.gov Identifier: NCT00657475|
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : May 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Surgery Extracorporeal Circulation||Drug: Heparin Low Dose Drug: Heparin Full Dose||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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.|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||March 2013|
Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin low dose (150 UI/Kg).
Drug: Heparin Low Dose
Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.
Active Comparator: 1
Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin Full Dose (300 UI/Kg)
Drug: Heparin Full Dose
Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.
- Blood loss [ Time Frame: Peroperative and postoperative until redon's suction drainage ablation ]
- Blood transfusion [ Time Frame: Per & postoperative ]
- Use of intropic drugs (posology) [ Time Frame: Postoperative ]
- Kidney function(urea, creatininemia) [ Time Frame: Postoperative ]
- Peroperative hemodynamic data [ Time Frame: Peroperative ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657475
|Cardiac Surgery Dpt (University Hospital)|
|Bordeaux, France, 33000|
|Principal Investigator:||Xavier ROQUES, PhD||University Hospital, Bordeaux|