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

October 18, 2017 updated by: Azienda Usl di Bologna

Investigation on the Prognostic Value of Biochemical Markers in the Cerebrospinal Fluid for the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40133
        • UOC Rianimazione CO e 118 Ospedale Maggiore AUSL
      • Bologna, Italy, 40133
        • UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL
    • Bologna
      • Imola, Bologna, Italy, 40026
        • Montecatone Rehabilitation Institute SpA
      • Ozzano, Bologna, Italy, 40064
        • Centro Interdipartimentale Ricerca Industriale Università degli Studi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: lumbar puncture
That's not really an arm label because the only intervention on the patients is the lumbar puncture
Other: Lumbar puncture
The only intervention is the lumbar puncture on the patients to obtain a Cerebrospinal Fluid sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Investigators

  • Principal Investigator: Giovanni Gordini, MD, Azienda Unità Sanitaria Locale Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 12105
  • RF-2010-2315118 (Other Identifier: Identification number assigned by Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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