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Intervention 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
Surgical fixation to be performed within 21 days of injury
Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years postoperation
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My surgery is scheduled within 3 weeks of my injury.
Select...
I need surgery for a spine injury in my chest or lower back area.
Select...
I am having a spinal fusion surgery involving more than 5 levels.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximal drop in systemic hemoglobin concentration during the postoperative period
Secondary outcome measures
Difference in costs for hospital stay between using tranexamic acid and placebo
Number of complications
Patient assessed health-related quality of life score
+2 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.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,581 Total Patients Enrolled
Ronald A Lehman, MDPrincipal InvestigatorColumbia University

Frequently Asked Questions

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

How can I sign up to participate in this research?

"Spinal injury patients that are between 18-80 years old may qualify for this trial. Right now, the clinical study has 252 open slots for participants."

Answered by AI

Is this study looking for more test subjects at the moment?

"The clinicaltrials.gov website says that this trial is still looking for volunteers. The study was first posted on June 15th 2020, with the most recent update taking place on March 7th 2022."

Answered by AI

What is the main reason that people are given this Intervention medication?

"Intervention is an effective medical treatment for hyperfibrinolysis, hemophilia, and other bleeding disorders."

Answered by AI

Are there historical examples of Intervention's efficacy in a medical setting?

"The intervention was first studied in 2010 Guangzhou TCM University. As of right now, a total of 18468 studies have been completed. Out of the 68 active trials, many are taking place Durham, North carolina."

Answered by AI

Is this study currently enrolling patients who are over the age of 50?

"As this study is only open to applicants aged 18-80, there are 67 other trials that might be more appropriate for minors and 385 studies better suited for senior citizens."

Answered by AI

Is this study widely available to patients in the United States?

"There are several locations where this trial is accepting patients, some of which include Duke University Medical Center in Durham, North carolina as well as Norton Leatherman Spine Center in Louisville, Kentucky."

Answered by AI

How many individuals are presently enrolled in this trial?

"252 patients that fit the given inclusion criteria are needed to enroll at various sites, such as Duke University Medical Center and Norton Leatherman Spine Center."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Im hoping this clinical trial will help my condition and also get to make better choices for it.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Tranexamic Acid to Reduce Blood Loss in Spine Trauma Surgery
Ronald A. Lehman 2020. "Tranexamic Acid to Reduce Blood Loss in Spine Trauma Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02314988.
All > North Carolina > Scoliosis
~59 spots leftby Jul 2025
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