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Prognostic Value of Biochemical Markers in Cerebrospinal Fluid for Functional Outcome of Spinal Cord Injured Patients

Investigation on the Prognostic Value of Biochemical Markers in the Cerebrospinal Fluid for the Functional Outcome of Spinal Cord Injured Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01861808
Enrollment
10
Registered
2013-05-24
Start date
2013-08-24
Completion date
2017-08-31
Last updated
2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries, Cerebrospinal Fluid

Brief summary

The project is aimed to develop predictive indices of spinal cord injury severity through the analysis of cerebrospinal fluid of patient collected during acute injury.

Interventions

OTHERLumbar puncture

The only intervention is the lumbar puncture on the patients to obtain a Cerebrospinal Fluid sample

Sponsors

Azienda Usl di Bologna
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* presence of cervical and thoracic Spinal Cord Injury * need to be submitted to spine surgical stabilization with posterior approach

Exclusion criteria

* prior to recruitment, in the acute phase, treatment with steroid therapy

Design outcomes

Primary

MeasureTime frameDescription
Creation of a model which analyze relationship among laboratory investigations and primary lesion, secondary damage and functional impairmentThree yearsCorrelation of the dosage of more than 20 tentative biomarkers with the biological effect of Cerebrospinal Fluid exposure on human cell lines, in order to directly test those effects. The Cerebrospinal Fluid will be encoded using technical procedures, divided into aliquots, quickly frozen and stored at 80°C. Biomarkers will be measured in the Cerebrospinal Fluid, related to: * inflammatory and vascular reaction, by a cytokine panel including 12 different cytokines/chemochines; * neurodegeneration and excitotoxicity, by a panel of 10 different biomarkers.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026