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Tranexamic Acid for Limb Salvage in Pediatric Bone Tumors and Cancer
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.
- Limb Salvage
- Bone Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 29 Patients • NCT02063035Trial Design
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Who is running the clinical trial?
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- You have allergies to medications that prevent excessive bleeding.You have a known condition that makes you more likely to bleed.You have a history of blood clots or currently have a blood clot.You have a history of disease affecting the brain or spinal cord.You cannot have a surgery that involves major blood vessels in your limbs.You have had seizures in the past, except if they were febrile seizures (seizures caused by a high fever).You are having surgery to remove a cancerous bone tumor in your leg and this surgery usually requires blood transfusions.
- Group 1: Tranexamic Acid
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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.,"
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."
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."
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