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Trial record 68 of 993 for:    Heparin sodium

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657475
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : May 7, 2013
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Surgery Extracorporeal Circulation Drug: Heparin Low Dose Drug: Heparin Full Dose Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : June 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Blood loss [ Time Frame: Peroperative and postoperative until redon's suction drainage ablation ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657475

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

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Responsible Party: University Hospital, Bordeaux Identifier: NCT00657475     History of Changes
Other Study ID Numbers: CHUBX 2007/19
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

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

Additional relevant MeSH terms:
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Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action