ThromboembolismPhase 4NCT00444652
Thromboprophylaxis and Bariatric Surgery
A Phase 4 study testing Enoxaparin in people with Thromboembolism, run by University Hospital, Strasbourg, France at 10 sites in France.
Trial summary
This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery. gastric banding and gastric bypass on anti-Xa activity levels The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thromboembolism
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 10 sitesFrance
- Study dates
- Nov 2006to Dec 2012
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI over 40
- Gastric banding or gastric bypass
Who cannot join
- Renal insufficiency
- Thrombopenia
- Long term anticoagulant treatment
- Pregnancy
- Allergy to heparin
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Département d'Anesthésiologie Hôpital de Brabois
Nancy, Lorraine
Etienne Junke, MD, 33 612163929, e.junke@chu-nancy.fr
Etienne Junke, MD
- Recruiting
Laboratoire d'Hémostase Hôpital de Brabois
Nancy, Lorraine
Thomas Lecompte, MD, 33 383851015, thomas.lecompte@chu-nancy.fr
Thomas Lecompte, MD
- Recruiting
Service de Chirurgie Digestive Hôpital de Brabois
Nancy, Lorraine
Laurent Brunaud, MD, 33 3 83858585, i.brunaud@chu-nancy.fr
Laurent Brunaud, MD
- Recruiting
Service de chirurgie générale et digestive,Hôpital Hôtel Dieu
Nantes
karim Asehnoune, MD, 00 332 40.08.30.05, karim.asehnoune@chu-nantes.fr
Karim Asehnoune, MD
- Recruiting
Clinique de l'Orangerie
Strasbourg, Alsace
Bernard Vailly, MD, 33 388567300, BVAILLY@aol.com
Philippe Plobner, MD
- Recruiting
Département d'Anesthésiologie Hôpital Civil
Strasbourg, Alsace
Martine Figier, MD, 33 388117354, martine.figier@chru-strasbourg.fr
Martine Figier, MD
- Recruiting
Laboratoire d'hémostase Hôpital de Hautepierre
Strasbourg, Alsace
Lelia Grunebaum, MD, 3 3388127528, lelia.grunebaum@chru-strasbourg.fr
Lelia Grunebaum, MD
- Recruiting
Service de Chirurgie Digestive Hopital de Hautepierre
Strasbourg, Alsace
Serge Rohr, MD, 33 388127223, serge.rohr@chru-strasbourg.fr
Elisabeth Ackermann, MD
- Recruiting
Service de Chirurgie Générale et Endocrinienne Hôpital Civil
Strasbourg, Alsace
Michel Vix, MD, 33 388116883, michel.vix@chru-strasbourg.fr
Michel Vix, MD
- Recruiting
Centre investigation Clinique Hôpital Civil
Strasbourg
Pascal Bousquet, MD, 33 3881176768, pascal.bousquet@chru-strasbourg.fr
Pascal Bousquet, MD
About this study
Official title: Thromboprophylaxis During Bariatric Surgery
This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.
- gastric banding and gastric bypass on anti-Xa activity levels
The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.
Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.
- Conditions
- Thromboembolism
- Being tested
- Enoxaparin
- Keywords
- Thromboprophylaxis, Bariatric surgery, prevention of venous thromboembolism in bariatric surgery
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
injection of enoxaparin a few time
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses
Measured: 48 heures
Secondary outcomes (3)
Microparticles
Measured: day 0, 1, 9,30
Thrombotic events until D30
Measured: day 30
Bleeding events
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startNov 2006
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- French State, Sanofi
- Responsible party
- Sponsor
- Investigators
- Annick Steib, MD, Study director, Hôpitaux Universitaire de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444652
- Sponsor's protocol ID
- 3779
- Status last verified
- Jun 2012
- First submitted
- 7 Mar 2007
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.
PubMed 36413425
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboprophylaxis During Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00444652
- Acronym / sponsor ID
- 3779
- Conditions
- Thromboembolism
- Keywords
- Thromboprophylaxis, Bariatric surgery, prevention of venous thromboembolism in bariatric surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- French State, Sanofi
- Study start
- Nov 2006
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Mar 2007 (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.
This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.
- gastric banding and gastric bypass on anti-Xa activity levels
The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.
Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI over 40
- Gastric banding or gastric bypass
Key exclusion criteria (5 listed)
- Renal insufficiency
- Thrombopenia
- Long term anticoagulant treatment
- Pregnancy
- Allergy to heparin
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 |
|---|---|---|
| Enoxaparininjection of enoxaparin a few time | Drug | – |
Primary outcome
Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses
Time frame: 48 heures
3 secondary outcomes
Microparticles
Time frame: day 0, 1, 9,30
Thrombotic events until D30
Time frame: day 30
Bleeding events
Time frame: day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
- Derived from this study: PubMed 36413425Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.
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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.
Annick Steib, MD study director
Hôpitaux Universitaire de Strasbourg
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin in people with Thromboembolism, run by University Hospital, Strasbourg, France at 10 sites 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annick Steib, MD (33 3.88.11.54.10, annick.steib@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses (time frame: 48 heures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00444652, which also lists 1 linked publication.
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 2 Jul 2012.