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

University Hospital of Bordeaux

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery; Extracorporeal Circulation

Treatments: Drug: Heparin Low Dose; Drug: Heparin Full Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT00657475

CHUBX 2007/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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238 participants in 2 patient groups

2

Experimental group

Description:

Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin low dose (150 UI/Kg).

Treatment:

Drug: Heparin Low Dose

1

Active Comparator group

Description:

Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin Full Dose (300 UI/Kg)

Treatment:

Drug: Heparin Full Dose