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

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00657475
Acronym
APPACHES
Enrollment
238
Registered
2008-04-14
Start date
2008-06-01
Completion date
2013-03-01
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Extracorporeal Circulation

Keywords

Heparin low dose, Inflammation, Blood loss

Brief 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.

Detailed 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.

Interventions

DRUGHeparin Low Dose

Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.

DRUGHeparin Full Dose

Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Blood lossPeroperative and postoperative until redon's suction drainage ablation

Secondary

MeasureTime frame
Blood transfusionPer & postoperative
Use of intropic drugs (posology)Postoperative
Kidney function(urea, creatininemia)Postoperative
Peroperative hemodynamic dataPeroperative

Countries

France

Contacts

PRINCIPAL_INVESTIGATORXavier ROQUES, PhD

University Hospital, Bordeaux

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026