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Tranexamic Acid for Reducing Blood Loss During Surgery for Pelvic Mass

Q: What is the customary application of Arm I (tranexamic acid)?

Tranexamic acid (Arm I) has been traditionally prescribed to treat hyperfibrinolysis, but is also beneficial in treating hemophilia, bleeding episodes, and post-dental surgery.

Q: How many people are participating in the experiment?

Indeed, the clinicaltrials.gov website suggests that this trial is actively enrolling subjects. It was initially listed on May 19th 2017 and most recently revised on October 14th 2022; 80 participants are being sought from a single site.

Q: Could you please tell me if there is still an opportunity to participate in this clinical trial?

According to clinicaltrials.gov, this medical study remains open for recruitment of participants; the first report on it was posted in May 2017 and updated as recently as October 2022.

Q: Have any other trials been conducted with tranexamic acid as the primary agent?

Presently, 61 trials are underway for Arm I (tranexamic acid), with 26 of those operating at Phase 3. Primarily located in Kaohsiung City, Yanchao District, the investigation into this treatment is being conducted across 185 separate sites.

Phase < 1

Recruiting

Led By Valerae O Lewis

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Both male and female patients must have a pelvic tumor and are scheduled to have surgery at University of Texas (UT) Monroe Dunaway (MD) Anderson Cancer center that require hemipelvectomy, resulting in pelvic ring disruption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 7 days post-surgery

Awards & highlights

Study Summary

This trial is testing whether tranexamic acid can reduce blood loss in patients who are having surgery to remove a tumor in their pelvis.

Who is the study for?

This trial is for both children and adults with pelvic tumors who are scheduled for hemipelvectomy surgery at UT MD Anderson Cancer Center. It's not for those with clotting disorders, thromboembolic disease, pregnant or nursing women, color vision defects, severe kidney issues, seizure disorders, recent intracranial hemorrhage, or allergy to tranexamic acid.Check my eligibility

What is being tested?

The study is testing if tranexamic acid can reduce blood loss in patients undergoing hemipelvectomy surgery due to pelvic tumors. Tranexamic acid works by stabilizing clots and preventing them from breaking down during surgery.See study design

What are the potential side effects?

Tranexamic acid may cause side effects such as nausea, diarrhea, seizures in individuals predisposed to them; it could also increase the risk of blood clots although this trial excludes patients already at high risk.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a pelvic tumor and am scheduled for surgery at UT MD Anderson that involves removing part of my pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss

Secondary outcome measures

Change in laboratory measurements

Complications including but not limited to venous thromboembolism, stroke, seizure, vision changes, and return to operating room (hematoma, active bleeding)

Length of ICU and hospital stay

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (no tranexamic acid)Experimental Treatment1 Intervention

Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (tranexamic acid)Experimental Treatment2 Interventions

Patients receive tranexamic acid IV over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,993 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,241 Total Patients Enrolled

Valerae O LewisPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

375 Total Patients Enrolled

Frequently Asked Questions

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

What is the customary application of Arm I (tranexamic acid)?

"Tranexamic acid (Arm I) has been traditionally prescribed to treat hyperfibrinolysis, but is also beneficial in treating hemophilia, bleeding episodes, and post-dental surgery."

Answered by AI

How many people are participating in the experiment?

"Indeed, the clinicaltrials.gov website suggests that this trial is actively enrolling subjects. It was initially listed on May 19th 2017 and most recently revised on October 14th 2022; 80 participants are being sought from a single site."

Answered by AI

Could you please tell me if there is still an opportunity to participate in this clinical trial?

"According to clinicaltrials.gov, this medical study remains open for recruitment of participants; the first report on it was posted in May 2017 and updated as recently as October 2022."

Answered by AI

Have any other trials been conducted with tranexamic acid as the primary agent?

"Presently, 61 trials are underway for Arm I (tranexamic acid), with 26 of those operating at Phase 3. Primarily located in Kaohsiung City, Yanchao District, the investigation into this treatment is being conducted across 185 separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery

2017. "Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03128866.