Venous Thromboembolic DiseaseENOX-VTD-HNCT05150314
Comparative Study of the Hemorrhagic Risk in Patients Over 75 Years of Age Taking Enoxaparin
An observational study of Venous Thromboembolic Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Elderly subjects are at greater risk of thrombophlebitis than the general population, but also of bleeding when anticoagulant therapy is initiated. Enoxaparin is one of the most widely used anticoagulants in the management of venous thromboembolism in the world. Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Venous Thromboembolic Disease
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2021to 18 Apr 2023
- Phase
- Observational
- 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 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: - Subjects of age> = 75 years and having a weight> = 45kg for women and> = 57kg for men and a BMI <30, a GFR> 30 ml / min in Cockcroft-Gault, and having benefited from treatment with Enoxaparin for deep vein thrombosis and / or pulmonary embolism between 01/01/2000 to 11/30/2021.
Who may be able to join
- Subjects of age> = 75 years
- Having a weight> = 45kg for women and> = 57kg for men and a BMI <30, a GFR> 30 ml / min in Cockcroft-Gault, and having benefited from treatment with Enoxaparin for deep vein thrombosis and / or pulmonary embolism between 01/01/2000 to 11/30/2021.
- Subject having been informed by posting in the service and / or via the welcome booklet and not having expressed his opposition to the reuse of his data.
Who cannot join
- Subject having expressed opposition to participating in the study
- History of heparin-induced thrombocytopenia in the last 100 days,
- condition associated with a high risk of bleeding such as congenital or acquired blood pathology,
- a recent hemorrhagic stroke,
- a gastrointestinal ulcer,
- the presence of a malignant tumor at high risk of bleeding, recent surgery of the brain, spine or ophthalmology, known or suspected oesophageal varices, arteriovenous malformations, a vascular aneurysm or major intraspinal or intracerebral vascular anomalies.
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Gériatrie. Soins de Longue Durée - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Alexander BOUSSUGE, MD, 33 3 88 11 54 61, alexandre.boussuge@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Comparative Study of the Hemorrhagic Risk in Patients Over 75 Years of Age Taking Enoxaparin at a Fixed Curative Dose of 4000 IU Twice a Day Versus at Dose / Weight Twice a Day as Part of the Treatment of Venous Thromboembolic Disease
Elderly subjects are at greater risk of thrombophlebitis than the general population, but also of bleeding when anticoagulant therapy is initiated.
Enoxaparin is one of the most widely used anticoagulants in the management of venous thromboembolism in the world.
Read more
Its use is not codified in the elderly, because too few studies have been carried out in people over 75 years old.
For several years, Enoxaparin in curative treatment has been administered at a reduced dosage of 4000 IU twice a day (and not at a standard dose of 100 IU / kg) at the Geriatrics center of the CRHU in Strasbourg with the clinical impression of a reduction the risk of serious bleeding without reduction in therapeutic efficacy in this very elderly population.
Confirmation of a reduction in the risk of bleeding at this dosage could be the start of a change in prescribing practices, towards a more suitable dosage in the elderly.
- Conditions
- Venous Thromboembolic Disease
- Keywords
- Thrombophlebitis, Anticoagulant therapy, Enoxaparin, Venous Thromboembolic Disease
- Medical subject headings
- Thrombophlebitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the risk of bleeding in patients over 75 years of age taking Enoxaparin at a fixed curative dose of 4000 IU twice a day
Measured: Files analysed retrospectively from January 01, 2000 to November 30, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start18 Nov 2021
- Primary completionApr 2023 (estimated)
- Study completion18 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander BOUSSUGE, MD, Principal investigator, Service de Gériatrie. Soins de Longue Durée - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150314
- Sponsor's protocol ID
- 8426
- Acronym
- ENOX-VTD-H
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Hemorrhagic Risk in Patients Over 75 Years of Age Taking Enoxaparin at a Fixed Curative Dose of 4000 IU Twice a Day Versus at Dose / Weight Twice a Day as Part of the Treatment of Venous Thromboembolic Disease
- ClinicalTrials.gov ID
- NCT05150314
- Acronym / sponsor ID
- ENOX-VTD-H / 8426
- Conditions
- Venous Thromboembolic Disease
- Keywords
- Thrombophlebitis, Anticoagulant therapy, Enoxaparin, Venous Thromboembolic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- 18 Apr 2023 (estimated)
- First posted
- 9 Dec 2021 (actual)
- 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.
Elderly subjects are at greater risk of thrombophlebitis than the general population, but also of bleeding when anticoagulant therapy is initiated.
Enoxaparin is one of the most widely used anticoagulants in the management of venous thromboembolism in the world.
Its use is not codified in the elderly, because too few studies have been carried out in people over 75 years old.
For several years, Enoxaparin in curative treatment has been administered at a reduced dosage of 4000 IU twice a day (and not at a standard dose of 100 IU / kg) at the Geriatrics center of the CRHU in Strasbourg with the clinical impression of a reduction the risk of serious bleeding without reduction in therapeutic efficacy in this very elderly population.
Confirmation of a reduction in the risk of bleeding at this dosage could be the start of a change in prescribing practices, towards a more suitable dosage in the elderly.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- - Subjects of age> = 75 years and having a weight> = 45kg for women and> = 57kg for men and a BMI <30, a GFR> 30 ml / min in Cockcroft-Gault, and having benefited from treatment with Enoxaparin for deep vein thrombosis and / or pulmonary embolism between 01/01/2000 to 11/30/2021.
Key inclusion criteria (3 listed)
- Subjects of age> = 75 years
- Having a weight> = 45kg for women and> = 57kg for men and a BMI <30, a GFR> 30 ml / min in Cockcroft-Gault, and having benefited from treatment with Enoxaparin for deep vein thrombosis and / or pulmonary embolism between 01/01/2000 to 11/30/2021.
- Subject having been informed by posting in the service and / or via the welcome booklet and not having expressed his opposition to the reuse of his data.
Key exclusion criteria (6 listed)
- Subject having expressed opposition to participating in the study
- History of heparin-induced thrombocytopenia in the last 100 days,
- condition associated with a high risk of bleeding such as congenital or acquired blood pathology,
- a recent hemorrhagic stroke,
- a gastrointestinal ulcer,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study of the risk of bleeding in patients over 75 years of age taking Enoxaparin at a fixed curative dose of 4000 IU twice a day
Time frame: Files analysed retrospectively from January 01, 2000 to November 30, 2021 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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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.
Saïd CHAYER, PhD, HDR contact
Alexander BOUSSUGE, MD principal investigator
Service de Gériatrie. Soins de Longue Durée - Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolic Disease, run by University Hospital, Strasbourg, France 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 3 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. 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.
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 Alexandre BOUSSUGE, MD (33 3 88 11 54 61, alexandre.boussuge@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the risk of bleeding in patients over 75 years of age taking Enoxaparin at a fixed curative dose of 4000 IU twice a day (time frame: Files analysed retrospectively from January 01, 2000 to November 30, 2021 will be examined]). 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 9 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.