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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01861808
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Lumbar puncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigation on the Prognostic Value of Biochemical Markers in the Cerebrospinal Fluid for the Functional Outcome of Spinal Cord Injured Patients
Actual Study Start Date : August 24, 2013
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861808


Locations
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Italy
Montecatone Rehabilitation Institute SpA
Imola, Bologna, Italy, 40026
Centro Interdipartimentale Ricerca Industriale Università degli Studi
Ozzano, Bologna, Italy, 40064
UOC Rianimazione CO e 118 Ospedale Maggiore AUSL
Bologna, Italy, 40133
UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL
Bologna, Italy, 40133
Sponsors and Collaborators
Azienda Usl di Bologna
Investigators
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Principal Investigator: Giovanni Gordini, MD Azienda Unità Sanitaria Locale Bologna
Publications:

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Responsible Party: Azienda Usl di Bologna
ClinicalTrials.gov Identifier: NCT01861808    
Other Study ID Numbers: CE 12105
RF-2010-2315118 ( Other Identifier: Identification number assigned by Ethics Committee )
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: April 2017
Keywords provided by Azienda Usl di Bologna:
Spinal Cord Injuries
Cerebrospinal Fluid
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries