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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-18

Study Completion Date

2023-04-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis (i.e., Preventive Treatment) for Venous Thromboembolism (VTE, i.e., Blood Clots in the Veins) and Bleeding Event Risk in a Population With Acute Medical Illness

NCT05819112

Venous Thromboembolism

TERMINATED

Venous Thromboembolic Prophylaxis After Trauma: Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin

NCT01729559

Venous Thromboembolic Disease Deep Vein Thrombosis Pulmonary Embolism

COMPLETED PHASE4

Early Versus Late Resumption of Anticoagulation in Patients With Both High Thrombosis Risk and Major HEmoRrhage

NCT02091479

Major hæmorrhage

TERMINATED PHASE3

Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis

NCT00277394

Deep Vein Thrombosis

COMPLETED PHASE4

Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism

NCT00413374

Deep Vein Thrombosis Pulmonary Embolism

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Thromboembolic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No