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Blood test may predict spinal injury recovery

NCT ID NCT06839300

Knowledge-focused Sponsor: AO Foundation, AO Spine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is looking at whether measuring two proteins in the blood (NF-L and GFAP) soon after a spinal cord injury can help doctors predict how severe the injury is and how much recovery a person might have 6 months later. Researchers will enroll 260 adults with traumatic spinal cord injuries and take blood samples daily for up to a week. The goal is to see if these blood markers can accurately tell apart people who will have a complete motor injury from those who will have some movement preserved.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

240 SCI patients with AIS grade A, B, C and D. And 20 non-SCI spine trauma control participants.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 19 years * Blunt (non-penetrating) traumatic SCI * Baseline neurologic impairment deemed "complete" (AIS grade A) or "incomplete" (AIS grade B, C, or D) based on clinical history/examination and/or diagnostic imaging * Bony spinal level involvement between C0 and L1, inclusive * Ability to have initial blood sample drawn within 24 hours of injury * Treated either surgically or non-surgically * Ability to provide informed consent according to the IRB/EC defined and approved procedures Inclusion criteria for non-spinal cord injury spinal trauma control participants: * Age ≥ 19 years * Traumatic spinal fracture and/or dislocation between C0 and L1 (inclusive) without SCI * Treated either surgically or nonsurgically * Ability to have initial blood sample drawn within 24 hours of injury * Ability to provide informed consent according to the IRB/EC defined and approved procedures Exclusion Criteria: * Penetrating SCI (eg, gunshot, stab) * Previous SCI * Isolated spinal injury below L1 * Isolated radiculopathy without fracture * Isolated cauda equina injury * Patients with known diagnosis of multiple sclerosis * Preexisting thromboembolic disease or coagulopathy (disorders related to blood clotting), such as hemophilia or von Willebrand disease * Patients who in the investigator's opinion will not be compliant with the study procedures and patients who have any other conditions/injuries that in the investigator's opinion would render the study procedures dangerous

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Conditions

The condition(s) this trial relates to.

spinal cord injury spinal fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cajuru University Hospital

    NOT_YET_RECRUITING

    Curitiba, Paraná, 80050-350, Brazil

  • Charité Berlin

    NOT_YET_RECRUITING

    Berlin, 10117, Germany

  • Clinica Alemana de Santiago

    RECRUITING

    Santiago, Vitacura, 5951, Chile

  • King's College Hospital

    NOT_YET_RECRUITING

    London, SE5 9RS, United Kingdom

  • MIddlemore Hospital

    NOT_YET_RECRUITING

    Auckland, Otahuhu, 1640, New Zealand

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Prince of Wales Hospital

    NOT_YET_RECRUITING

    Sydney, Randwick NSW, 2031, Australia

  • Sri Balaji Action Medical Institute

    NOT_YET_RECRUITING

    New Delhi, 110063, India

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