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

NCT ID: NCT01861808

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-24

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Spinal Cord Injuries

Keywords

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Spinal Cord Injuries Cerebrospinal Fluid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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lumbar puncture

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

Group Type OTHER

Lumbar puncture

Intervention Type OTHER

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

Interventions

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Lumbar puncture

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Usl di Bologna

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Gordini, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Unità Sanitaria Locale Bologna

Locations

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Montecatone Rehabilitation Institute SpA

Imola, Bologna, Italy

Site Status

Centro Interdipartimentale Ricerca Industriale Università degli Studi

Ozzano Monferrato, Bologna, Italy

Site Status

UOC Rianimazione CO e 118 Ospedale Maggiore AUSL

Bologna, , Italy

Site Status

UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL

Bologna, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 11586111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21559420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20038240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21175377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21731081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21394541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17978014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11805601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19061765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20130419 (View on PubMed)

Other Identifiers

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RF-2010-2315118

Identifier Type: OTHER

Identifier Source: secondary_id

CE 12105

Identifier Type: -

Identifier Source: org_study_id