Are Uterine Fibroids Pro-thrombotic?

NCT05607602 | Active Not Recruiting

• 1 other identifier: 301611
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Leiomyoma, Uterine; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Assess for the presence of a laboratory pro-thrombotic phenotype in patients with UF

  1 day (Snapshot in time)

Secondary Outcomes (2)

• Assess for normalisation of the pro-thrombotic phenotype post-surgery for uterine fibroids

  6 to 12 weeks post operatively

• Assess for a correlation between overall uterine size and fibroid volume and markers of a pro-thrombotic phenotype

  1 day (Snapshot in time)

Study Arms (3)

1

Women with uterine fibroids, not requiring any medical or surgical treatment.

Other: Comparison of blood samples between the two groups

1a

Women with uterine fibroids undergoing myomectomy or hysterectomy for uterine fibroids

Group 2

Women with no uterine fibroids or uterine pathology on ultrasound scan

Other: Comparison of blood samples between the two groups

Interventions

Comparison of blood samples between the two groups OTHER

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.

1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 - 65 years with uterine fibroids confirmed on ultrasound able to provide informed consent

You may qualify if:

• Group 1: 35 patients with ultrasound confirmed uterine fibroids. Group 1a: 35 patients with ultrasound confirmed uterine fibroids requiring myomectomy or hysterectomy.
• Group 2: 35 control patients with a normal pelvis on ultrasound Able to provide informed consent

You may not qualify if:

• Pregnant
• Post- partum (within 6 weeks)
• Surgery within 90 days
• Family history of thrombosis (first degree relative)
• Co-morbidities: cancer, liver impairment, renal impairment, uncontrolled hypertension
• Medication: Oral contraception containing oestrogen, hormone replacement therapy with oral oestrogen, antiplatelet therapy, anticoagulation
• Tranexamic Acid within last 48hrs, Zoladex within the last 33 days
• Smoker
• If anaemia (Hb \<110 g/L) is demonstrated on the study sample taken

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Hemab ApS: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Leiomyoma; Thrombosis

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: November 7, 2022
• Study Start: October 17, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)