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

Cardiac Surgery Clinical Trial

— APPACHES  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657475
• Other study ID #: CHUBX 2007/19
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2008
• Last updated: May 6, 2013
• Start date: June 2008
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Surgery
• Extracorporeal Circulation

Intervention

Drug:
• Heparin Low Dose
Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.
• Heparin Full Dose
Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.

Locations

Country	Name	City	State
France	Cardiac Surgery Dpt (University Hospital)	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss		Peroperative and postoperative until redon's suction drainage ablation	Yes
Secondary	Blood transfusion		Per & postoperative	Yes
Secondary	Use of intropic drugs (posology)		Postoperative	Yes
Secondary	Kidney function(urea, creatininemia)		Postoperative	Yes
Secondary	Peroperative hemodynamic data		Peroperative	No