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

NCT05150314 | Unknown

• 1 other identifier: 8426
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolic Disease

Keywords

Thrombophlebitis; Anticoagulant therapy; Enoxaparin; Venous Thromboembolic Disease

Outcome Measures

Primary Outcomes (1)

• 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]

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Gériatrie. Soins de Longue Durée - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Thrombophlebitis

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Phlebitis; Peripheral Vascular Diseases; Vasculitis

Study Officials

• Alexander BOUSSUGE, MD

  Service de Gériatrie. Soins de Longue Durée - Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre BOUSSUGE, MD

CONTACT

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

Saïd CHAYER, PhD, HDR

CONTACT

said.chayer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 9, 2021
• Study Start: November 18, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 18, 2023
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

FR (1)