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Antifibrinolytic Agent

Tranexamic Acid for Limb Salvage in Pediatric Bone Tumors and Cancer

Phase 3
Waitlist Available
Led By Michael D. Neel, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant undergoing limb salvage procedure of malignant bone tumor of the distal femur or proximal tibia, which typically requires blood transfusions
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operatively (no more than 7 days prior to start of therapy), daily while inpatient and post operatively (approximately 1 week post-op)
Awards & highlights

Study Summary

This trial is testing whether Tranexamic acid can decrease blood loss and transfusion requirements in pediatric and young adult cancer patients undergoing a limb salvage procedure.

Eligible Conditions
  • Limb Salvage
  • Bone Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are having surgery to remove a cancerous bone tumor in your leg and this surgery usually requires blood transfusions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and during 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
Difference in intra-operatively transfused blood volume (mL/kg)
Difference in post-operatively transfused blood volume (mL/kg)
Secondary outcome measures
Changes in estimated blood loss (EBL)
Changes in hemoglobin level (g/dL)
Changes in platelet level
+2 more

Side effects data

From 2015 Phase 4 trial • 29 Patients • NCT02063035
8%
Postoperative wound infection
8%
Postoperative wound infection after release from hospital
8%
Myocardial infaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tranexamic Acid

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic AcidExperimental Treatment1 Intervention
At initiation of surgical preparation, participants randomized to the active treatment arm will receive tranexamic acid 10 mg/kg (max 1 g), given via syringe pump programmed to infuse over 15 minutes. If no unacceptable toxicities occur, a second dose of tranexamic acid IV push over 5 to 15 minutes will be given 6 hours (with a window of +/- 30 minutes) after the first dose (either intra- or post-operatively).
Group II: PlaceboPlacebo Group1 Intervention
At initiation of surgical preparation, participants randomized to the placebo treatment arm will receive 0.9% sodium chloride (salt water). It will be matched in appearance, volume, and administration to the active treatment arm with tranexamic acid. If no unacceptable toxicities occur, a second dose of placebo IV push over 5 to 15 minutes will be given 6 hours (with a window of +/- 30 minutes) after the first dose (either intra- or post-operatively).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic Acid
2011
Completed Phase 4
~3930

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
426 Previous Clinical Trials
5,306,590 Total Patients Enrolled
Michael D. Neel, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Tranexamic Acid (Antifibrinolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04410042 — Phase 3
Limb Salvage Research Study Groups: Tranexamic Acid, Placebo
Limb Salvage Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT04410042 — Phase 3
Tranexamic Acid (Antifibrinolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04410042 — Phase 3

Frequently Asked Questions

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

What is the primary indication for Tranexamic Acid?

"Tranexamic Acid is used to treat hyperfibrinolysis. It can also be used as a prophylactic measure for those with hemophilia or those who are about to undergo a tooth extraction."

Answered by AI

Are there any unfilled positions for participants in this clinical trial?

"Yes, this trial is still seeking participants. According to the information on clinicaltrials.gov, the study was first posted on January 29th 2021 and was last edited on October 24th 2022."

Answered by AI

How many people are total are included in this experiment?

"That is accurate. The clinical trial is currently underway and is looking for 39 patients from 1 location, as stated on the website."

Answered by AI

What are the researchers attempting to discover with this clinical trial?

"The primary outcome of this trial, which will be assessed over approximately during surgery, is to difference in post-operatively transfused blood volume (mL/kg). Secondary objectives include changes in hemoglobin level (g/dL) which is defined as summary statistics will be provided for the decline in hemoglobin from pre-op to post-op level, for both the TXA and placebo group. Two sample t-test or Wilcoxon rank sum test will be used to compare the differences between the two groups. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.,"

Answered by AI

What other medical studies have involved Tranexamic Acid in the past?

"At the moment, there are 69 ongoing clinical trials that are researching Tranexamic Acid. Out of those, 29 are in Phase 3. Even though the majority of studies for Tranexamic Acid are based in Kansas City, Kansas, there are a total of 305 locations running studies for this treatment."

Answered by AI

Has Tranexamic Acid been cleared for use by the FDA?

"Tranexamic Acid has been evaluated for safety in Phase 3 trials, which means that there is both efficacy and safety data available. Our team has assessed the safety to be a 3 on a scale from 1 to 3."

Answered by AI
~4 spots leftby Mar 2025