Cardiac SurgeryPhase 4APPACHESNCT00657475
Coronary Bypass and Artotic Leaflet Surgery : Heparin Low Dose vs Full Dose
A Phase 4 study testing Heparin Low Dose and Heparin Full Dose in people with Cardiac Surgery and Extracorporeal Circulation, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Extracorporeal Circulation
- What is being tested?
- Heparin Low Dose and Heparin Full Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Thoracic surgery antecedent
- ASA 4
- carotid stenosis > 75%
- Hb < 10,5 g/l
- chronic hepatic failure
- thromboembolic antecedent
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
Read the 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.
- Conditions
- Cardiac Surgery, Extracorporeal Circulation
- Being tested
- Heparin Low Dose, Heparin Full Dose
- Keywords
- Heparin low dose, Inflammation, Blood loss
- Medical subject headings
- Inflammation, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin Low DoseDrug
Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.
Heparin Full DoseDrug
Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin low dose (150 UI/Kg). Receives: Drug: Heparin Low Dose |
| 1 | Active comparator | Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin Full Dose (300 UI/Kg) Receives: Drug: Heparin Full Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Measured: Peroperative and postoperative until redon's suction drainage ablation
Secondary outcomes (4)
Blood transfusion
Measured: Per & postoperative
Use of intropic drugs (posology)
Measured: Postoperative
Kidney function(urea, creatininemia)
Measured: Postoperative
Peroperative hemodynamic data
Measured: Peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier ROQUES, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657475
- Sponsor's protocol ID
- CHUBX 2007/19
- Other IDs
- 2007-005070-31
- Acronym
- APPACHES
- Status last verified
- May 2013
- First submitted
- 8 Apr 2008
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00657475
- Acronym / sponsor ID
- APPACHES / CHUBX 2007/19
- Conditions
- Cardiac Surgery, Extracorporeal Circulation
- Keywords
- Heparin low dose, Inflammation, Blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Heparin Low DoseCardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin low dose (150 UI/Kg). |
| 1 | Active comparator | Drug: Heparin Full DoseCardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin Full Dose (300 UI/Kg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Thoracic surgery antecedent
- ASA 4
- carotid stenosis > 75%
- Hb < 10,5 g/l
- chronic hepatic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin Low DoseLoading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds. | Drug | 2 |
| Heparin Full DoseLoading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds. | Drug | 1 |
Primary outcome
Blood loss
Time frame: Peroperative and postoperative until redon's suction drainage ablation
4 secondary outcomes
Blood transfusion
Time frame: Per & postoperative
Use of intropic drugs (posology)
Time frame: Postoperative
Kidney function(urea, creatininemia)
Time frame: Postoperative
Peroperative hemodynamic data
Time frame: Peroperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier ROQUES, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin Low Dose and Heparin Full Dose in people with Cardiac Surgery and Extracorporeal Circulation, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: Peroperative and postoperative until redon's suction drainage ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.