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Clinical Trials/NCT05150314
NCT05150314
Unknown
Not Applicable

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

University Hospital, Strasbourg, France1 site in 1 country2,000 target enrollmentNovember 18, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous Thromboembolic Disease
Sponsor
University Hospital, Strasbourg, France
Enrollment
2000
Locations
1
Primary Endpoint
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
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2021
End Date
April 18, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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