Fibrin clot structure and thrombin production after urogynecological surgery
Fibrin Clot Properties and Thrombin Generation in Women After Urogynecological Surgery.
Jagiellonian University · NCT07295782
This project will test whether blood fibrin clot properties and thrombin generation change in women after surgery for uterine prolapse or urinary incontinence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Jagiellonian University (other) |
| Locations | 1 site (Krakow, Małopolska) |
| Trial ID | NCT07295782 on ClinicalTrials.gov |
What this trial studies
This observational project measures blood fibrin clot properties and thrombin generation in women after urogynecological surgery for uterine prolapse or urinary incontinence. Blood samples will be analyzed for clot permeability, susceptibility to fibrinolysis, and thrombin generation assays. Eligible participants are women aged 18–70 who undergo surgery after pharmacologic treatment failure, excluding those with congenital or acquired thrombophilia or prolonged thromboprophylaxis. No investigational treatments are given; clinical data and laboratory measurements will be correlated to characterize postoperative clotting phenotypes.
Who should consider this trial
Good fit: Women aged 18–70 having surgery for uterine prolapse or urinary incontinence after pharmacologic treatment failure, without known congenital or acquired thrombophilia, are ideal candidates.
Not a fit: Patients with known thrombophilia, those on prolonged thromboprophylaxis, or those undergoing other planned surgeries are unlikely to benefit from the study's specific findings.
Why it matters
Potential benefit: If successful, the findings could help identify women at higher postoperative clotting risk and guide more personalized thromboprophylaxis.
How similar studies have performed: Clot-phenotype and thrombin generation measurements have been informative in thrombosis research broadly, but applying these assays specifically after urogynecological surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 * treatment failure (pharmacotherapy) due to uterine prolapse or urine incontinence Exclusion Criteria: * prolonged thromboprophylaxis * planned surgery other than due to urine incontinence/uterine prolapse * acquired or congenital thrombophilia
Where this trial is running
Krakow, Małopolska
- Gynecological Endocrinology Department — Krakow, Małopolska, Poland (RECRUITING)
Study contacts
- Study coordinator: Magdalena MP Piróg, MD, PhD
- Email: magda.m.pulka@gmail.com
- Phone: +48 604514915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Uterine Prolapse, Urine Incontinence, uterine prolapse, urine incontinence, fibrin clot, fibrinolysis, thrombin