NCT05150314

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 76 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2021-11-18
• Primary completion: 2023-04-01
• Completion: 2023-04-18
• First posted: 2021-12-09
• Last updated: 2021-12-09

Locations

1 site across 1 country: France