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Antifibrinolytic Agent

Tranexamic Acid for Spine Surgery Patients

Phase < 1
Recruiting
Led By Bryce Basques, MD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for an open posterior thoracolumbar spinal fusion procedure
Be older than 18 years old
Must not have
Renal impairment
Severe pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing whether giving multiple doses of the drug tranexamic acid, either orally or by IV, can reduce blood loss and the need for transfusions after spine surgery.

Who is the study for?
This trial is for adults over 18 scheduled for open posterior thoracolumbar spinal fusion surgery. It's not suitable for those allergic to TXA, refusing blood products, with recent heart attacks, severe lung or liver disease, color vision issues, recent anticoagulant use, kidney impairment, pregnant or breastfeeding women, and those with a history of clotting disorders.
What is being tested?
The study tests if multiple doses of oral Tranexamic Acid (TXA) can reduce post-surgery blood loss and transfusion needs compared to a single dose regimen. It also compares the effectiveness of oral TXA against intravenous delivery in patients undergoing spine surgery.
What are the potential side effects?
Potential side effects may include reactions at the injection site from IV TXA and gastrointestinal discomfort from oral tablets. There could be an increased risk of clotting due to TXA's blood-clot preventing properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a specific back surgery involving the spine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have kidney problems.
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I have a severe lung condition.
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I refuse to receive blood transfusions.
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I have problems seeing colors correctly.
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I have severe heart disease that limits my daily activities.
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I have liver failure.
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I have had a heart attack before.
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I have had blood clots or stroke-related conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 4 Full Oral TXAExperimental Treatment1 Intervention
Group II: Group 3 Pre-Oral TXAExperimental Treatment2 Interventions
Group III: Group 2 IV TXAExperimental Treatment2 Interventions
Group IV: Group 1 PLACEBOPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
248,760 Total Patients Enrolled
Bryce Basques, MDPrincipal InvestigatorRush University Medical Center

Media Library

Tranexamic Acid (Antifibrinolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03849443 — Phase < 1
Posterior Spinal Fusion Procedure Research Study Groups: Group 1 PLACEBO, Group 2 IV TXA, Group 3 Pre-Oral TXA, Group 4 Full Oral TXA
Tranexamic Acid (Antifibrinolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03849443 — Phase < 1
Posterior Spinal Fusion Procedure Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT03849443 — Phase < 1
~97 spots leftby Dec 2025
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