Clinical trial NCT06419075: Tranexamic Acid in Vaginal Reconstructive Surgery
Official title: Local Infiltration of TranExamic Acid in Surgical Management of Pelvic Organ Prolapse: a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Keywords: Tranexamic Acid
Colpocleisis
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: MOUNT SINAI HOSPITAL
name: The University of Texas Health Science Center, Houston
First posted: 2024-05-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The enrolled subjects will be randomized into one of the 3 arms including tranexamic acid (2 mg/dL), vasopressin (0.1 U/dL), and normal saline.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a multicenter, double blinded, pilot randomized clinical trial that will be conducted at UTMB Health, and other participating sites. Each participating site will obtain IRB approval. Women with symptomatic, stage II to IV Pelvic organ prolapse (POP) who plan colpocleisis will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessment will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to the local TXA, or Vasopressin, or NS group with the total sample size of 36 female subjects (12 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. The anesthesia team is responsible for preparing the study agents, monitoring intraoperative cardiovascular parameters (blood pressure and heart rate) as well as adverse events, and determining the blood transfusion if needed. Subsequently, the subject will have postoperative follow up at 2 weeks and 6 weeks

Eligibility criteria: Inclusion Criteria:

1. Females who are menopausal at the time of consent
2. Able to understand and read English
3. Able and willing to provide written informed consent
4. Able to comply with the follow-up study protocol, per clinician judgment
5. Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV
6. LeFort or complete colpocleisis as desired surgical approach to correct POP with and without other concomitant procedures
7. History of abdominal or vaginal surgery for POP
8. American Society of Anesthesiologists (ASA) physical status I or II

Exclusion Criteria:

1. Texas Department of Criminal Justice prisoners
2. Refusal of blood products (e.g, Jehovah's witnesses)
3. ASA physical status III or IV
4. Known allergy or hypersensitivity to TXA or any of the ingredients
5. Subarachnoid hemorrhage
6. Active intravascular clotting, thromboembolic disease (cerebral thrombosis, deep vein thrombosis, or pulmonary embolism)
7. Epilepsy, seizure disorders requiring anti-epileptic medication(s)
8. Acquired impaired color vision (color blindness, retinal involvement)
9. Intrinsic risk of thrombosis or thromboembolism (hypercoagulopathy, thrombogenic cardiac rhythm disease, thrombogenic valvular disease)
10. History of severe liver disease
11. Known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol
12. History of cardiac diseases (decompensated congestive heart failure CHF, recent coronary artery disease CAD within 30 days, recent myocardial infarction MI within 30 days)
13. History of reversible nephrogenic diabetes insipidus
14. History of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis
15. Prior or current pelvic radiation, or chemotherapy.
16. Females who desires to have vaginal sexual intercourse after the surgery

Primary outcomes:
measure: Intraoperative quantitative blood loss QBL (mL)
timeFrame: Intraoperatively
Secondary outcomes:
measure: Colpocleisis operative time (min)
timeFrame: Intraoperatively
measure: Intraoperative blood pressure (mmHg)
timeFrame: Intraoperatively
measure: Intraoperative hear rate (beats/min)
timeFrame: Intraoperatively
measure: Postoperative complications
timeFrame: 2 weeks and 6 weeks postoperatively
measure: Rate of transfusion
timeFrame: Intraoperatively and 2 weeks postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas Medical Branch Galveston
name: Gokhan Kilic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Hospital & Medical Center
name: Ann Tran, MD
role: PRINCIPAL_INVESTIGATOR
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