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Completed

NCT Number: NCT00657475

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiac Surgery Dpt (University Hospital)

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heparin Low Dose

Drug

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

Heparin Full Dose

Drug

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

Primary outcomes

  1. Blood loss

    Time frame: Peroperative and postoperative until redon's suction drainage ablation

Secondary outcomes

  1. Blood transfusion

    Time frame: Per & postoperative

  2. Use of intropic drugs (posology)

    Time frame: Postoperative

  3. Kidney function(urea, creatininemia)

    Time frame: Postoperative

  4. Peroperative hemodynamic data

    Time frame: Peroperative

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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.

Acronym: APPACHES

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 14, 2008
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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