Tranexamic Acid in Vaginal Reconstructive Surgery (NCT06419075) | Clinical Trial Compass
WithdrawnPhase 4
Tranexamic Acid in Vaginal Reconstructive Surgery
Stopped: closed study due to lack of faculty
0Started 2024-07-01
Plain-language summary
Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies. As a result of this evidence for benefit, TXA is routinely used to reduce blood loss during these surgeries. There are no studies regarding the use of TXA in urogynecology. The investigators seek to explore the effect and safety of local infiltration of TXA in vaginal reconstructive surgery.
Who can participate
Age range50 Years – 100 Years
SexFEMALE
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Inclusion criteria
✓. Females who are menopausal at the time of consent
✓. Able to understand and read English
✓. Able and willing to provide written informed consent
✓. Able to comply with the follow-up study protocol, per clinician judgment
✓. Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV
✓. LeFort or complete colpocleisis as desired surgical approach to correct POP with and without other concomitant procedures
✓. History of abdominal or vaginal surgery for POP
✓. American Society of Anesthesiologists (ASA) physical status I or II
Exclusion criteria
✕. Texas Department of Criminal Justice prisoners
✕. Refusal of blood products (e.g, Jehovah's witnesses)
✕. ASA physical status III or IV
✕. Known allergy or hypersensitivity to TXA or any of the ingredients
✕. Subarachnoid hemorrhage
✕. Active intravascular clotting, thromboembolic disease (cerebral thrombosis, deep vein thrombosis, or pulmonary embolism)
What they're measuring
1
Intraoperative quantitative blood loss QBL (mL)
Timeframe: Intraoperatively
Trial details
NCT IDNCT06419075
SponsorThe University of Texas Medical Branch, Galveston