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Antifibrinolytic agent

Tranexamic Acid for Uterine Fibroids

Phase 3

Recruiting

Led By Seifeldin Sadek, MD

Research Sponsored by Eastern Virginia Medical School

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any intramural or broad ligament fibroid greater than or equal to 4 cm

Undergoing laparoscopic myomectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of surgery up to 420 minutes

Awards & highlights

Study Summary

This trial is testing whether or not the injection of TXA can reduce blood loss during surgery for uterine fibroids.

Who is the study for?

This trial is for women aged 18-45 with abnormal uterine bleeding due to fibroids, who are undergoing laparoscopic myomectomy. They must have at least one large fibroid or multiple smaller ones and no history of blood clots, stroke, severe organ issues, or certain medication use that could interfere with the study.Check my eligibility

What is being tested?

The study tests if Tranexamic Acid (TXA) can reduce bleeding during minimally invasive surgery for uterine fibroids. Participants will either receive TXA or a placebo before surgery in this double-blinded trial where neither they nor the doctors know who gets which treatment.See study design

What are the potential side effects?

Tranexamic Acid may cause side effects like nausea, diarrhea, muscle cramps, and risks related to clotting such as deep vein thrombosis. However, participants with known clotting risks are excluded from this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a fibroid that is 4 cm or larger.

Select...

I am scheduled for a laparoscopic surgery to remove fibroids.

Select...

I have a fibroid that is 6 cm or larger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of randomization until postoperative visit, four weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of randomization until postoperative visit, four weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of randomization until postoperative visit, four weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Calculated blood loss

Estimated blood loss

Number of blood products received

Secondary outcome measures

Duration of surgery

Fibroid type

Incidence of postoperative complication

+8 more

Side effects data

From 2015 Phase 4 trial • 29 Patients • NCT02063035

Postoperative wound infection

Postoperative wound infection after release from hospital

Myocardial infaction

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tranexamic Acid

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tranexamic AcidExperimental Treatment1 Intervention

Patients will receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline 15 minutes prior to initial surgical incision time

Group II: PlaceboPlacebo Group1 Intervention

Patients will receive an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic Acid

2011

Completed Phase 4

~2740

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eastern Virginia Medical SchoolLead Sponsor

69 Previous Clinical Trials

14,401 Total Patients Enrolled

Seifeldin Sadek, MDPrincipal InvestigatorEastern Virginia Medical School

Media Library

Tranexamic Acid (Antifibrinolytic agent) Clinical Trial Eligibility Overview. Trial Name: NCT04311073 — Phase 3

Uterine Fibroids Research Study Groups: Tranexamic Acid, Placebo

Uterine Fibroids Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT04311073 — Phase 3

Tranexamic Acid (Antifibrinolytic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04311073 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the specific inclusion criteria for this trial?

"This research is looking for 50 individuals between 18-45 years of age that have current vaginal bleeding. Furthermore, the perfect candidate would also meet the following conditions: Having at least one fibroid greater than or equal to 6 cm, Any intramural or broad ligament fibroid greater than or equal to 4 cm, At least 3 total fibroids based on preoperative imaging, and finally someone who is undergoing laparoscopic myomectomy."

Answered by AI

What are some of Tranexamic Acid's common uses?

"Tranexamic Acid is a medication used to stop the break down of blood clots. It's frequently given to patients with hyperfibrinolysis, but can also be useful for those with hemophilia, abnormal bleeding, or who are about to have a tooth extracted."

Answered by AI

Could you tell me if the age limit for this research project is 70 years old or younger?

"For this particular study, patients between 18-45 years old are eligible to apply. There are 12 trials for patients under the age of majority and 83 clinical trials available for seniors."

Answered by AI

Is this the first time Tranexamic Acid has been used in a clinical trial?

"Currently, there are 68 ongoing studies involving Tranexamic Acid. Out of these, 29 are in Phase 3. Most trials for this medication are based out of Kansas City, but there are 304 locations conducting research on Tranexamic Acid."

Answered by AI

When was Tranexamic Acid cleared by the FDA?

"Tranexamic Acid is safe according to our scale because it has reached Phase 3 in clinical trials. This signifies that, not only does the medication have some evidence of being effective, but there is also multiple rounds of data supporting its safety."

Answered by AI

Recent research and studies

Cochrane Database of Systematic ReviewsJournal

Anti-fibrinolytic Use for Minimising Perioperative Allogeneic Blood Transfusion

Henry, David A, Paul A Carless, Annette J Moxey, Dianne O'Connell, Barrie J Stokes, Dean A Fergusson, and Katharine Ker. 2011. “Anti-fibrinolytic Use for Minimising Perioperative Allogeneic Blood Transfusion”. Edited by David A Henry. Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd. doi:10.1002/14651858.cd001886.pub3.

Journal of Minimally Invasive GynecologyJournal

Use of Intravenous Tranexamic Acid During Myomectomy: A Randomized Double-blind Placebo Controlled Trial

Opoku-Anane, J, MV Vargas, G Moawad, M Cherie, and JK Robinson. 2015. “Use of Intravenous Tranexamic Acid During Myomectomy: A Randomized Double-blind Placebo Controlled Trial”. Journal of Minimally Invasive Gynecology. Elsevier BV. doi:10.1016/j.jmig.2015.08.715.

Fertility and SterilityJournal

Uterine Myomas: Management

Parker, William H.. 2007. “Uterine Myomas: Management”. Fertility and Sterility. Elsevier BV. doi:10.1016/j.fertnstert.2007.06.044.

American Journal of Obstetrics and GynecologyJournal