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The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 5 of 12 entries
    • Study description revised
    • Site details revised at 2 of 8 sites
  2. Site details revised at 1 of 8 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2025 to Feb 9, 2026
    • Study sites: 0 to 8
    v3
  4. Start date: Jun 1, 2025 to Nov 1, 2025v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D) a group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.
Trial Details
NCT Number NCT06839300
Lead Sponsor AO Foundation, AO Spine
Conditions
(from sponsor)		 Spinal Cord Injury
Related terms Spinal Cord Injuries
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov