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Tranexamic Acid for Reducing Blood Loss During Surgery for Pelvic Mass

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 weeks
Treatment ~ Varies
Follow Up ~up to 7 days post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days post-surgery 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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,719 Previous Clinical Trials
40,963,478 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,992 Previous Clinical Trials
1,792,575 Total Patients Enrolled
Valerae O LewisPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
375 Total Patients Enrolled
~17 spots leftby May 2026
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