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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00657475
First received: April 8, 2008
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Cardiac Surgery
Extracorporeal Circulation
Drug: Heparin Low Dose
Drug: Heparin Full Dose
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Blood loss [ Time Frame: Peroperative and postoperative until redon's suction drainage ablation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood transfusion [ Time Frame: Per & postoperative ] [ Designated as safety issue: Yes ]
  • Use of intropic drugs (posology) [ Time Frame: Postoperative ] [ Designated as safety issue: Yes ]
  • Kidney function(urea, creatininemia) [ Time Frame: Postoperative ] [ Designated as safety issue: Yes ]
  • Peroperative hemodynamic data [ Time Frame: Peroperative ] [ Designated as safety issue: No ]

Enrollment: 238
Study Start Date: June 2008
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin low dose (150 UI/Kg).
Drug: Heparin Low Dose
Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.
Active Comparator: 1
Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin Full Dose (300 UI/Kg)
Drug: Heparin Full Dose
Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657475

Locations
France
Cardiac Surgery Dpt (University Hospital)
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Xavier ROQUES, PhD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00657475     History of Changes
Other Study ID Numbers: CHUBX 2007/19
Study First Received: April 8, 2008
Last Updated: May 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Heparin low dose
Inflammation
Blood loss

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014