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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

Must not have

Patients will not be eligible if they present with moderate to severe decrease in creatinine clearance (estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73m2)

Patient with a history of genetic prothrombotic state

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 7 days post-surgery

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is normal or only slightly reduced.

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I have a genetic condition that increases my risk of blood clots.

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I have a history of blood clots in my lungs or legs.

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I have not had a brain bleed in the last 6 months.

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I am not pregnant or nursing.

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I have never had seizures or a seizure disorder.

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I have never had a blockage in the blood vessels of my eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met