UnknownNot Applicable

Comparative Study of the Hemorrhagic Risk in Patients Over 75 Years of Age Taking Enoxaparin

France2,000 participantsStarted 2021-11-18

Plain-language 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. 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.

Who can participate

Age range

76 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * 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. Exclusion criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Files analysed retrospectively from January 01, 2000 to November 30, 2021 will be examined]

Trial details

NCT IDNCT05150314

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04

Contact for this trial

Alexandre BOUSSUGE, MD

33 3 88 11 54 61 alexandre.boussuge@chru-strasbourg.fr

View on ClinicalTrials.gov More Venous Thromboembolic Disease trials