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ACTIVE NOT RECRUITING
NCT05607602

Are Uterine Fibroids Pro-thrombotic?

Sponsor: King's College Hospital NHS Trust

View on ClinicalTrials.gov

Summary

This study will investigate whether the presence of uterine fibroids is independently associated with a laboratory defined pro-thrombotic phenotype. VTE is associated with significant mortality and morbidity. In addition, treating patients with UF and thrombosis represents a particular challenge as fibroids frequently cause menorrhagia, which is exacerbated by anticoagulation. It is therefore important to recognise and detect risk factors and prevent thrombosis wherever possible. If a pro-thrombotic phenotype is detected in patients with UF as their sole risk factor, then this could justify a new approach to the assessment and risk-management of a very large number of patients and could translate into a reduction in both morbidity and mortality for affected patients.

Official title: Does the Presence of Uterine Fibroids Cause Changes in the Blood That Increase the Risk of Clots?

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

105

Start Date

2022-10-17

Completion Date

2024-12-31

Last Updated

2024-06-11

Healthy Volunteers

Yes

Interventions

OTHER

Comparison of blood samples between the two groups

In this study we will perform global haemostatic assays such as activated partial thromboplastic time (APTT), and prothrombin time (PT). However, these tests provide information about the haemostatic process until the point of initial fibrin formation and ignore the procedure of thrombin generation\[18\]. In this study we will perform Thrombin Generation studies, Plasma clot Lysis, and RNA sequencing in addition to standard laboratory tests (APTT, PT, FVIII:C, fibrinogen (using Clauss methods), platelet count, liver and renal function tests.

Locations (1)

King's College Hospital

London, United Kingdom