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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montecatone Rehabilitation Institute SpA, Imola, Bologna, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar puncture

Other

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

Primary outcomes

Creation of a model which analyze relationship among laboratory investigations and primary lesion, secondary damage and functional impairment

Time frame: Three years
Correlation 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.

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2017
First posted: May 24, 2013
Registry last updated: Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed