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Coronary Bypass and Artotic Leaflet Surgery : Heparin Low Dose vs Full Dose (APPACHES)
This study is currently recruiting participants.
Verified by University Hospital, Bordeaux, June 2008
Sponsored by: University Hospital, Bordeaux
Information provided by: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00657475
  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 IV

MedlinePlus related topics: Blood Thinners Coronary Artery Bypass Surgery Heart Surgery
Drug Information available for: Heparin
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment: 240
Study Start Date: June 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Experimental
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.
1: Active Comparator
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) Recruiting
Bordeaux, France, 33000
Contact: Xavier ROQUES, Pr     05 57 65 64 56     xavier.roques@chu-bordeaux.fr    
Contact: Pierre OSES         pierreoses@tiscali.fr    
Principal Investigator: Xavier ROQUES, PhD            
Sub-Investigator: Nadine LABORDE, Dr            
Sub-Investigator: Jean-Philippe GUIBAUD, Dr            
Sub-Investigator: Nicolas ELIA, Dr            
Sub-Investigator: Joachim CALDERON, Dr            
Sub-Investigator: Philippe RICHEBE, Dr            
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Xavier ROQUES, PhD University Hospital, Bordeaux
  More Information

Responsible Party: University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers: CHUBX 2007/19
Study First Received: April 8, 2008
Last Updated: June 23, 2008
ClinicalTrials.gov Identifier: NCT00657475  
Health Authority: France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Calcium, Dietary
Hemorrhage
Heparin
Calcium heparin
Inflammation

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

ClinicalTrials.gov processed this record on January 16, 2009