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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: Lumbar puncture

• 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

Study Timeline

• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-24
• Study Start: 2013-08-24
• Primary Completion: 2016-09-01
• Status Verified: 2017-04
• Study Completion: 2017-08-31
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lumbar puncture	Lumbar puncture	That's not really an arm label because the only intervention on the patients is the lumbar puncture

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.

Trial Locations

Locations (4)

Centro Interdipartimentale Ricerca Industriale Università degli Studi; 🇮🇹 Ozzano, Bologna, Italy

UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL; 🇮🇹 Bologna, Italy

Montecatone Rehabilitation Institute SpA; 🇮🇹 Imola, Bologna, Italy

UOC Rianimazione CO e 118 Ospedale Maggiore AUSL; 🇮🇹 Bologna, Italy