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Sponsored by: |
University Hospital, Bordeaux |
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Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00657475 |
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 |
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Cardiac Surgery Extracorporeal Circulation |
Drug: Heparin Low Dose Drug: Heparin Full Dose |
Phase IV |
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. |
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 |
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2: Experimental
Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin low dose (150 UI/Kg).
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Drug: Heparin Low Dose
Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.
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1: Active Comparator
Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin Full Dose (300 UI/Kg)
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Drug: Heparin Full Dose
Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Xavier ROQUES, PhD | University Hospital, Bordeaux |
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 |
Heparin low dose Inflammation Blood loss |
Calcium, Dietary Hemorrhage Heparin Calcium heparin Inflammation |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |