Tranexamic Acid in Vaginal Reconstructive Surgery (TEXAS)

January 28, 2025 updated by: The University of Texas Medical Branch, Galveston

Local Infiltration of TranExamic Acid in Surgical Management of Pelvic Organ Prolapse: a Pilot Randomized Clinical Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77554
        • University of Texas Medical Branch Galveston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal Saline (NaCl 0.9%)
Local infiltration of 50 cc NaCl 0.9% into the vaginal submucosa during colpocleisis dissection
Other: NaCl 0.9%
The intervention of 50 cc NaCl 0.9% local infiltration serves a placebo control.
Experimental: Tranexamic Acid (2 mg/dL)
Local infiltration of 50 cc Tranexamic Acid (2 mg/dL) into the vaginal submucosa during colpocleisis dissection
Drug: Tranexamic acid
The intervention of 50 cc TXA (2 mg/mL) local infiltration is determined after carefully reviewing the literature. Scarafoni et al. recommends that the local TXA should not exceed at a concentration of 5-10 mg/mL to avoid cytotoxicity that may affect the wound re-epithelialization (22). In a prospective study on facelift bleeding, Kochuba et al. demonstrates that local TXA (1-2 mg/mL) with total 100 mg and 200 mg TXA safely and effectively decreased bleeding, operating room time, and drain output compared with traditional local anesthetic technique (14). Fathimani et all reports the local use of modified tumescent anesthesia solution with low TXA concentration (2 mg/dL) and total average dosage of TXA ranging 120-1000 mg is safe and promising in achieving less ecchymosis, edema, and seroma in common facial cosmetic surgical procedures (31). With a total dosage of 100 mg TXA and a volume of 50 cc injection, the concentration is calculated to be 2 mg/dL.
Other Names:
  • Tranexamic acid (CYKLOKAPRON) (Pfizer, New York, NY).
Experimental: Vasopressin (0.1 U/dL)
Local infiltration of 50 cc Vasopressin (0.1 U/dL) into the vaginal submucosa during colpocleisis dissection
Drug: Vasopressin
The intervention of 50 cc Vasopressin (0.1U/mL) local infiltration is determined from several systematic reviews. Hafidh et al. shows that injection of diluted Vasopressin (3.6 to 10 units) with various concentration during hysterectomy significantly reduces the intraoperative blood loss when compared to placebo, and without increasing the hazard of cardiovascular toxicities. Cui et al. reports similar results, but including other vaginal surgeries. The common preparation for dilute Vasopressin is 0.1 U/mL or 1.0 U/mL from a 1cc vial of 20 U/mL Vasopressin. The advantage of 0.1 U/mL concentration is to avoid a relatively large bolus of concentrated 1.0 U/mL Vasopressin injected intravascularly by accident. A cumulative total dose of 4 to 6 units of Vasopressin administered in a dilute solution is proposed to be an upper limit. Therefore, the cumulative total dose of 5 units Vasopressin from 50 cc (0.1U/mL) is in the safe therapeutic range.
Other Names:
  • Vasopressin (Vasostrict) (Par Pharmaceutical, Chestnut Ridge, NY).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative quantitative blood loss QBL (mL)
Time Frame: Intraoperatively
Compare intraoperative QBL during colpocleisis with the local infiltration of Tranexamic acid to the current standard of care, vasopressin or normal saline.
Intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colpocleisis operative time (min)
Time Frame: Intraoperatively
Compare the colpocleisis operative time between Tranexamic acid, vasopressin or normal saline groups
Intraoperatively
Intraoperative blood pressure (mmHg)
Time Frame: Intraoperatively
Evaluate the effect blood pressures at 1, 5, and 10 mins after the local infiltration of Tranexamic acid, vasopressin and NS into the vaginal mucosa.
Intraoperatively
Intraoperative hear rate (beats/min)
Time Frame: Intraoperatively
Evaluate the effect on heart rate at 1, 5, and 10 mins after the local infiltration of Tranexamic acid, vasopressin and NS into the vaginal mucosa.
Intraoperatively
Postoperative complications
Time Frame: 2 weeks and 6 weeks postoperatively
Assess postoperative complications following colpocleisis using the Clavien-Dindo Classification (CDC) categories
2 weeks and 6 weeks postoperatively
Rate of transfusion
Time Frame: Intraoperatively and 2 weeks postoperatively
Quantify the need for blood-product transfusion and the volume administered as a direct result of colpocleisis, either intraoperative or postoperative
Intraoperatively and 2 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

The University of Texas Health Science Center, Houston
MOUNT SINAI HOSPITAL

Investigators

  • Principal Investigator: Gokhan Kilic, MD, University of Texas Medical Branch Galveston
  • Principal Investigator: Ann Tran, MD, Mount Sinai Hospital & Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Actual)

January 27, 2025

Study Completion (Actual)

January 27, 2025

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are not planning to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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