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Anti-fibrinolytic agent
Tranexamic Acid for Prolapse (TEXAS Trial)
Phase 4
Waitlist Available
Led By Gokhan Kilic, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females who are menopausal at the time of consent
LeFort or complete colpocleisis as desired surgical approach to correct POP with and without other concomitant procedures
Must not have
Refusal of blood products (e.g, Jehovah's witnesses)
Subarachnoid hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperatively and 2 weeks postoperatively
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
"This trial aims to investigate the effects and safety of using tranexamic acid in vaginal reconstructive surgery, as it has been shown to reduce blood loss in other types of surgeries."
Who is the study for?
This trial is for individuals undergoing vaginal reconstructive surgery due to pelvic organ prolapse. Specific eligibility criteria are not provided, but typically participants would need to be in good health and meet certain medical standards set by the study.
What is being tested?
The trial investigates if Tranexamic acid (TXA), which reduces blood loss in various surgeries, is also effective and safe when used locally during vaginal reconstructive surgery. It compares TXA with standard treatments like NaCl 0.9% and Vasopressin.
What are the potential side effects?
While specific side effects of TXA in this context aren't listed, common ones from other surgeries include nausea, vomiting, diarrhea, dizziness or muscle cramps. Risks may vary based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman and have gone through menopause.
Select...
I am considering or have chosen a specific surgery (LeFort or colpocleisis) for pelvic organ prolapse.
Select...
I feel a bulge or pressure due to vaginal prolapse, classified as Stage II-IV.
Select...
I have had surgery for pelvic organ prolapse.
Select...
I am in good or mild systemic disease condition according to ASA standards.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I refuse blood transfusions due to personal beliefs.
Select...
I have had a bleeding in the space around my brain.
Select...
I have a condition that increases my risk of blood clots.
Select...
I have a history of severe liver disease.
Select...
I have not had recent serious heart problems.
Select...
I have had reversible water balance issues due to kidney problems.
Select...
I have had cancer in my pelvic organs or cancer that has spread to my pelvis.
Select...
I have had radiation or chemotherapy targeting the pelvic area.
Select...
I have a serious but not life-threatening illness.
Select...
I have an active blood clotting disorder.
Select...
I am on medication for epilepsy or seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intraoperative quantitative blood loss QBL (mL)
Secondary study objectives
Colpocleisis operative time (min)
Intraoperative blood pressure (mmHg)
Intraoperative hear rate (beats/min)
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Vasopressin (0.1 U/dL)Experimental Treatment1 Intervention
Local infiltration of 50 cc Vasopressin (0.1 U/dL) into the vaginal submucosa during colpocleisis dissection
Group II: Tranexamic Acid (2 mg/dL)Experimental Treatment1 Intervention
Local infiltration of 50 cc Tranexamic Acid (2 mg/dL) into the vaginal submucosa during colpocleisis dissection
Group III: Normal Saline (NaCl 0.9%)Placebo Group1 Intervention
Local infiltration of 50 cc NaCl 0.9% into the vaginal submucosa during colpocleisis dissection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vasopressin
2014
Completed Phase 4
~24780
Tranexamic acid
2018
Completed Phase 4
~42540
Find a Location
Who is running the clinical trial?
MOUNT SINAI HOSPITALOTHER
42 Previous Clinical Trials
16,948 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
957 Previous Clinical Trials
347,816 Total Patients Enrolled
The University of Texas Medical Branch, GalvestonLead Sponsor
254 Previous Clinical Trials
57,219 Total Patients Enrolled
2 Trials studying Pelvic Organ Prolapse
50 Patients Enrolled for Pelvic Organ Prolapse
Gokhan Kilic, MDPrincipal InvestigatorUniversity of Texas Medical Branch Galveston
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
40 Patients Enrolled for Pelvic Organ Prolapse
Ann Tran, MDPrincipal InvestigatorMount Sinai Hospital & Medical Center
1 Previous Clinical Trials
103 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
103 Patients Enrolled for Pelvic Organ Prolapse