Are Uterine Fibroids Pro-thrombotic?
Research type
Research Study
Full title
Does the presence of uterine fibroids cause changes in the blood that increase the risk of clots?
IRAS ID
301611
Contact name
Obianuju Nzelu
Contact email
Sponsor organisation
King's College Hospital NHS Trust
Duration of Study in the UK
1 years, 6 months, 5 days
Research summary
An association between Venous Thromboembolic disease and uterine fibroids (UF) has been inferred in case reports, series, and one population-based study. The true prevalence and the full scale of the problem is unknown. In most of the reported case studies, bulky tumours cause extrinsic compression of pelvic vessels, venous stasis and thus thrombosis. Alternatively, fibroids may mediate an indirect pro-thrombotic effect by inducing iron deficiency anaemia, which has been associated with thrombotic events, most commonly cerebral venous thrombosis, but also Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT).
A clinical case review reported by our centre has identified women with thrombosis and UF that do not cause local venous stasis and no additional risk factors for thrombosis. A second centre has also published a case review, similarly identifying an apparent association between UF and thrombosis in the absence of venous stasis. This suggests that there may be additional pathogenic mechanisms underlying the development of thrombosis in individuals with UF.
We propose to collect blood samples and clinical data from patients with ultrasound confirmed uterine fibroids and patients with a normal pelvis on ultrasound. We will assess for the presence of a laboratory pro-thrombotic phenotype on coagulation screen, plasma clot lysis, thrombin generation studies and RNA sequencing in patients with UF compared to those with a normal pelvis.
VTE is associated with significant mortality and morbidity. Additionally, treating patients with UF and thrombosis represents a particular challenge as fibroids frequently cause menorrhagia, which is exacerbated by anticoagulation. 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.
REC name
London - London Bridge Research Ethics Committee
REC reference
21/LO/0867
Date of REC Opinion
15 Jan 2022
REC opinion
Further Information Favourable Opinion