Comparative Study of the Hemorrhagic Risk in Patients Over 75 Years of Age Taking Enoxaparin (ENOX-VTD-H)

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.

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 Overview

• Status: Recruiting
• Conditions: Venous Thromboembolic Disease

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Alexandre BOUSSUGE, MD; Phone Number: 33 3 88 11 54 61; Email: alexandre.boussuge@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Gériatrie. Soins de Longue Durée - Hôpitaux Universitaires de Strasbourg
    • Sub-Investigator: François LEFEBVRE, Statistician
    • Contact: Alexander BOUSSUGE, MD; Phone Number: 33 3 88 11 54 61; Email: alexandre.boussuge@chru-strasbourg.fr
    • Principal Investigator: Alexander BOUSSUGE, MD
    • Sub-Investigator: Marie-Pauline DEBROS, MD
    • Sub-Investigator: Thomas VOGEL, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 76 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Files analysed retrospectively from January 01, 2000 to November 30, 2021 will be examined]

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Alexander BOUSSUGE, MD, Service de Gériatrie. Soins de Longue Durée - Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 18, 2023

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Enoxaparin; Venous Thromboembolic Disease; Thrombophlebitis; Anticoagulant therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: 8426 (Duke legacy protocol number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No