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

May 6, 2013 updated by: University Hospital, Bordeaux

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Cardiac Surgery Dpt (University Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood loss
Time Frame: Peroperative and postoperative until redon's suction drainage ablation
Peroperative and postoperative until redon's suction drainage ablation

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood transfusion
Time Frame: Per & postoperative
Per & postoperative
Use of intropic drugs (posology)
Time Frame: Postoperative
Postoperative
Kidney function(urea, creatininemia)
Time Frame: Postoperative
Postoperative
Peroperative hemodynamic data
Time Frame: Peroperative
Peroperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Xavier ROQUES, PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 6, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2007/19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Clinical Trials on Heparin Low Dose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe