search
Back to results

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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lumbar puncture
Sponsored by
Azienda Usl di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Cerebrospinal Fluid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montecatone Rehabilitation Institute SpA
  • Centro Interdipartimentale Ricerca Industriale Università degli Studi
  • UOC Rianimazione CO e 118 Ospedale Maggiore AUSL
  • UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

lumbar puncture

Arm Description

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
May 15, 2013
Last Updated
October 18, 2017
Sponsor
Azienda Usl di Bologna
search

1. Study Identification

Unique Protocol Identification Number
NCT01861808
Brief Title
Prognostic Value of Biochemical Markers in Cerebrospinal Fluid for Functional Outcome of Spinal Cord Injured Patients
Official Title
Investigation on the Prognostic Value of Biochemical Markers in the Cerebrospinal Fluid for the Functional Outcome of Spinal Cord Injured Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 24, 2013 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Usl di Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries, Cerebrospinal Fluid

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lumbar puncture
Arm Type
Other
Arm Description
That's not really an arm label because the only intervention on the patients is the lumbar puncture
Intervention Type
Other
Intervention Name(s)
Lumbar puncture
Intervention Description
The only intervention is the lumbar puncture on the patients to obtain a Cerebrospinal Fluid sample
Primary Outcome Measure Information:
Title
Creation of a model which analyze relationship among laboratory investigations and primary lesion, secondary damage and functional impairment
Description
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.
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Gordini, MD
Organizational Affiliation
Azienda Unità Sanitaria Locale Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montecatone Rehabilitation Institute SpA
City
Imola
State/Province
Bologna
ZIP/Postal Code
40026
Country
Italy
Facility Name
Centro Interdipartimentale Ricerca Industriale Università degli Studi
City
Ozzano
State/Province
Bologna
ZIP/Postal Code
40064
Country
Italy
Facility Name
UOC Rianimazione CO e 118 Ospedale Maggiore AUSL
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL
City
Bologna
ZIP/Postal Code
40133
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
11586111
Citation
Dumont RJ, Verma S, Okonkwo DO, Hurlbert RJ, Boulos PT, Ellegala DB, Dumont AS. Acute spinal cord injury, part II: contemporary pharmacotherapy. Clin Neuropharmacol. 2001 Sep-Oct;24(5):265-79. doi: 10.1097/00002826-200109000-00003.
Results Reference
background
PubMed Identifier
21559420
Citation
Lubieniecka JM, Streijger F, Lee JH, Stoynov N, Liu J, Mottus R, Pfeifer T, Kwon BK, Coorssen JR, Foster LJ, Grigliatti TA, Tetzlaff W. Biomarkers for severity of spinal cord injury in the cerebrospinal fluid of rats. PLoS One. 2011 Apr 29;6(4):e19247. doi: 10.1371/journal.pone.0019247.
Results Reference
background
PubMed Identifier
20038240
Citation
Kwon BK, Stammers AM, Belanger LM, Bernardo A, Chan D, Bishop CM, Slobogean GP, Zhang H, Umedaly H, Giffin M, Street J, Boyd MC, Paquette SJ, Fisher CG, Dvorak MF. Cerebrospinal fluid inflammatory cytokines and biomarkers of injury severity in acute human spinal cord injury. J Neurotrauma. 2010 Apr;27(4):669-82. doi: 10.1089/neu.2009.1080.
Results Reference
background
PubMed Identifier
21175377
Citation
Kwon BK, Casha S, Hurlbert RJ, Yong VW. Inflammatory and structural biomarkers in acute traumatic spinal cord injury. Clin Chem Lab Med. 2011 Mar;49(3):425-33. doi: 10.1515/CCLM.2011.068. Epub 2010 Dec 23.
Results Reference
background
PubMed Identifier
21731081
Citation
Oyinbo CA. Secondary injury mechanisms in traumatic spinal cord injury: a nugget of this multiply cascade. Acta Neurobiol Exp (Wars). 2011;71(2):281-99.
Results Reference
background
PubMed Identifier
21394541
Citation
Pajoohesh-Ganji A, Byrnes KR. Novel neuroinflammatory targets in the chronically injured spinal cord. Neurotherapeutics. 2011 Apr;8(2):195-205. doi: 10.1007/s13311-011-0036-2.
Results Reference
background
PubMed Identifier
17978014
Citation
Rossignol S, Schwab M, Schwartz M, Fehlings MG. Spinal cord injury: time to move? J Neurosci. 2007 Oct 31;27(44):11782-92. doi: 10.1523/JNEUROSCI.3444-07.2007.
Results Reference
background
PubMed Identifier
11805601
Citation
Sekhon LH, Fehlings MG. Epidemiology, demographics, and pathophysiology of acute spinal cord injury. Spine (Phila Pa 1976). 2001 Dec 15;26(24 Suppl):S2-12. doi: 10.1097/00007632-200112151-00002.
Results Reference
background
PubMed Identifier
19061765
Citation
Tsai MC, Wei CP, Lee DY, Tseng YT, Tsai MD, Shih YL, Lee YH, Chang SF, Leu SJ. Inflammatory mediators of cerebrospinal fluid from patients with spinal cord injury. Surg Neurol. 2008 Dec;70 Suppl 1:S1:19-24; discussion S1:24. doi: 10.1016/j.surneu.2007.09.033.
Results Reference
background
PubMed Identifier
20130419
Citation
van den Berg ME, Castellote JM, Mahillo-Fernandez I, de Pedro-Cuesta J. Incidence of spinal cord injury worldwide: a systematic review. Neuroepidemiology. 2010;34(3):184-92; discussion 192. doi: 10.1159/000279335. Epub 2010 Feb 2.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs