NCT01861808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

August 24, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

October 19, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

May 15, 2013

Last Update Submit

October 18, 2017

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord InjuriesCerebrospinal Fluid

Outcome Measures

Primary Outcomes (1)

  • 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.

    Three years

Study Arms (1)

lumbar puncture

OTHER

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

Other: Lumbar puncture

Interventions

Lumbar punctureOTHER

The only intervention is the lumbar puncture on the patients to obtain a Cerebrospinal Fluid sample

lumbar puncture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Montecatone Rehabilitation Institute SpA

Imola, Bologna, 40026, Italy

Location

Centro Interdipartimentale Ricerca Industriale Università degli Studi

Ozzano Monferrato, Bologna, 40064, Italy

Location

UOC Rianimazione CO e 118 Ospedale Maggiore AUSL

Bologna, 40133, Italy

Location

UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL

Bologna, 40133, Italy

Location

Related Publications (10)

  • 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.

    PMID: 11586111BACKGROUND

  • 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.

    PMID: 21559420BACKGROUND

  • 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.

    PMID: 20038240BACKGROUND

  • 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.

    PMID: 21175377BACKGROUND

  • 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. doi: 10.55782/ane-2011-1848.

    PMID: 21731081BACKGROUND

  • 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.

    PMID: 21394541BACKGROUND

  • 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.

    PMID: 17978014BACKGROUND

  • 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.

    PMID: 11805601BACKGROUND

  • 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.

    PMID: 19061765BACKGROUND

  • 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.

    PMID: 20130419BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Giovanni Gordini, MD

    Azienda Unità Sanitaria Locale Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 24, 2013

Study Start

August 24, 2013

Primary Completion

September 1, 2016

Study Completion

August 31, 2017

Last Updated

October 19, 2017

Record last verified: 2017-04

Locations

IT(4)