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Antifibrinolytic Agent

Tranexamic Acid for Degenerative Disc Disease

Phase 2

Waitlist Available

Led By Mario Zanaty, M.D>

Research Sponsored by Royce W. Woodroffe, MD

Eligibility Criteria Checklist

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

Must have

American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV

Age 18-90 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 days or until discharge

Awards & highlights

Study Summary

This trial will compare the effects of tranexamic acid to placebo in patients undergoing lumber interbody fusion surgery.

Who is the study for?

Adults aged 18-90 with Degenerative Disc Disease (DDD) needing a lumbar interbody fusion surgery on at least two levels, who have not improved with physical therapy or injections. Excluded are those with other diseases prompting the surgery, liver failure, blood clotting issues, severe heart/lung disease, certain medication use including anticoagulants and antiplatelets, allergies to TXA, low platelet count or hemoglobin levels.Check my eligibility

What is being tested?

The trial is testing whether Tranexamic Acid (TXA), compared to a saline solution placebo given during spinal fusion surgery for DDD can reduce blood loss and transfusion need. It also looks at post-surgery confusion rates using the 3D-CAM interview method, inflammation markers in the body after surgery and how long patients stay in hospital.See study design

What are the potential side effects?

Tranexamic Acid may cause side effects such as increased risk of blood clots leading to deep vein thrombosis or pulmonary embolism. There's also potential for allergic reactions in those sensitive to TXA and an increase in seizure risk especially if there's a history of seizures.

Eligibility Criteria

Inclusion Criteria

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

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My spinal injury is classified between I and IV on the ASA scale.

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I am between 18 and 90 years old.

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I am having spine surgery for disc disease involving 2 or more levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 days or until discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 days or until discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days or until discharge for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Blood Loss

Delirium

Transfusion

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TreatmentActive Control3 Interventions

1:1 randomization, given tranexamic acid during surgery, visual acuity exam

Group II: PlaceboPlacebo Group3 Interventions

1:1 randomization, given standard of care treatment during surgery, visual acuity exam

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Royce W. Woodroffe, MDLead Sponsor

Mario ZanatyLead Sponsor

Catherine R. OlingerLead Sponsor

Media Library

Tranexamic Acid (Antifibrinolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04272606 — Phase 2

Degenerative Disc Disease Research Study Groups: Treatment, Placebo

Degenerative Disc Disease Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT04272606 — Phase 2

Tranexamic Acid (Antifibrinolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04272606 — Phase 2

Frequently Asked Questions

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

Has this medication been deemed safe by the FDA?

"This treatment received a score of 2, as there is some evidence pointing to its safety but it has not been proven effective yet."

Answered by AI

Could I possibly qualify to take part in this experiment?

"The study team is looking for 300 individuals that have intervertebral disc degeneration and meet the following conditions: being between 18-90 years old, having an American Spinal Injury Association (ASIA) Impairment Scale anesthesia risk of I to IV, having a Body Mass Index (BMI) below 35, needing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF., and finally candidates must have failed conservative management such as physical therapy (PT) or occupational therapy (OT)."

Answered by AI

Are there precedents for this proposed treatment plan?

"At the moment, there are 68 different clinical trials underway that are studying this treatment. Of these active studies, 29 are in Phase 3 and they're based all over the world in 304 different locations with a majority being concentrated in Kansas City, Kansas."

Answered by AI

Under what circumstances would this medication be given to a patient?

"This medical intervention is used to treat hyperfibrinolysis. It can also be employed in cases like hemophilia, where there is abnormal bleeding, and during tooth extractions."

Answered by AI

Are there any more open spots in this clinical trial for patients who wish to enroll?

"The clinicaltrials.gov listing for this trial shows that it is open and recruiting patients. This 300-person study was posted on August 1st, 2020 and last updated on October 13th, 2020 at a single site."

Answered by AI

Could you tell me if people who are under 25 years old can participate in this clinical trial?

"This study's age requirements are that potential participants must be between 18-90 years old."

Answered by AI

How many people are in this clinical trial?

"That is correct, the online clinicaltrial.gov registry has this listed as an ongoing study that began recruitment on 8/1/2020. The last update was 10/13/2022 and they are looking for 300 participants at 1 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TXA in Spinal Fusion

Catherine R. Olinger 2020. "TXA in Spinal Fusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04272606.

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