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NCT05607602
Are Uterine Fibroids Pro-thrombotic?
Conditions: Leiomyoma, Uterine, Thrombosis
Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Enrollment: 105
Sponsor: King's College Hospital NHS Trust
Location: United Kingdom
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.
Eligibility Criteria
Inclusion Criteria: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 consentExclusion Criteria:• Personal history of thrombosisPregnantPost- partum (within 6 weeks)Surgery within 90 daysFamily history of thrombosis (first degree relative)Co-morbidities: cancer, liver impairment, renal impairment, uncontrolled hypertensionMedication: Oral contraception containing oestrogen, hormone replacement therapy with oral oestrogen, antiplatelet therapy, anticoagulationTranexamic Acid within last 48hrs, Zoladex within the last 33 daysSmokerIf anaemia (Hb <110 g/L) is demonstrated on the study sample taken
Source: ClinicalTrials.gov (NCT05607602). StuddyBuddy aggregates publicly available trial information.