Coronary Bypass and Artotic Leaflet Surgery : Heparin Low Dose vs Full Dose

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Cardiac Surgery, Extracorporeal Circulation

Intervention / Treatment
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* Drug: Heparin Low Dose
* Drug: Heparin Full Dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: single or multiple coronary bypass written and informed consent repair or replacement of artic leaflet platelet suppressive agents stopped since at least 7 days anticoagulants stopped since at least 3 days Exclusion Criteria: Thoracic surgery antecedent ASA 4 carotid stenosis > 75% Hb < 10,5 g/l chronic hepatic failure thromboembolic antecedent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin low dose (150 UI/Kg). | Drug: Heparin Low Dose<br>* Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.<br>|
| Active Comparator: 1<br>Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin Full Dose (300 UI/Kg) | Drug: Heparin Full Dose<br>* Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss |  | Peroperative and postoperative until redon's suction drainage ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion |  | Per & postoperative | 
| Use of intropic drugs (posology) |  | Postoperative | 
| Kidney function(urea, creatininemia) |  | Postoperative | 
| Peroperative hemodynamic data |  | Peroperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heparin low dose, Inflammation, Blood loss