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Tranexamic Acid for Spinal Injury

Phase 2 & 3
Recruiting
Led By Ronald A Lehman, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years postoperation

Summary

This trial is designed to study whether tranexamic acid can reduce blood loss in patients who have sustained a spine injury requiring surgery. The study will last for two years and will compare outcomes in patients who receive tranexamic acid to those who receive a placebo.

Who is the study for?
Adults with thoracic or lumbar spine injuries from trauma or needing complex surgery, who can have surgery within 21 days of injury and require long spinal fusions. Excluded are those with low hemoglobin, recent anticoagulant use, severe brain injuries, other trial participation, certain blood disorders, pregnancy/breastfeeding, history of thrombosis or seizures, major organ damage or serious comorbidities.
What is being tested?
The study tests if tranexamic acid reduces blood loss during and after spine trauma surgery compared to a placebo. It's randomized and double-blind meaning neither the patients nor the doctors know who gets the real treatment versus saline solution. The follow-up is for two years with several check-ins.
What are the potential side effects?
Tranexamic acid could potentially cause side effects like increased risk of blood clots in veins or arteries (thrombosis), seizures in susceptible individuals, vision disturbances including color vision issues; it may also worsen outcomes if there's a subarachnoid hemorrhage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years postoperation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years postoperation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Difference in costs for hospital stay between using tranexamic acid and placebo
Number of complications
Patient assessed health-related quality of life score
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: InterventionActive Control1 Intervention
Subjects will receive tranexamic acid on the surgical wound.
Group II: Placebo controlPlacebo Group1 Intervention
Subjects will receive placebo (saline solution) on the surgical wound.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,662,938 Total Patients Enrolled
Ronald A Lehman, MDPrincipal InvestigatorColumbia University
~29 spots leftby Jul 2025
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