Prognostic Value of Biochemical Markers in Cerebrospinal Fluid for Functional Outcome of Spinal Cord Injured Patients
- Conditions
- Spinal Cord Injuries
- Registration Number
- NCT01861808
- Lead Sponsor
- Azienda Usl di Bologna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- presence of cervical and thoracic Spinal Cord Injury
- need to be submitted to spine surgical stabilization with posterior approach
- prior to recruitment, in the acute phase, treatment with steroid therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Creation of a model which analyze relationship among laboratory investigations and primary lesion, secondary damage and functional impairment 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Montecatone Rehabilitation Institute SpA
🇮🇹Imola, Bologna, Italy
Centro Interdipartimentale Ricerca Industriale Università degli Studi
🇮🇹Ozzano, Bologna, Italy
UOC Rianimazione CO e 118 Ospedale Maggiore AUSL
🇮🇹Bologna, Italy
UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL
🇮🇹Bologna, Italy
Montecatone Rehabilitation Institute SpA🇮🇹Imola, Bologna, Italy