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Are Uterine Fibroids Pro-thrombotic?

NCT05607602 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2024-06-11

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Hemab ApS

    collaborator INDUSTRY

  • King's College Hospital NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05607602 on ClinicalTrials.gov