Clinical trial NCT01861808: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries
Cerebrospinal Fluid
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2013-05-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Creation of a model which analyze relationship among laboratory investigations and primary lesion, secondary damage and functional impairment
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Imola
country: Italy
facility: Montecatone Rehabilitation Institute SpA
state: Bologna
city: Ozzano
country: Italy
facility: Centro Interdipartimentale Ricerca Industriale Università degli Studi
state: Bologna
city: Bologna
country: Italy
facility: UOC Rianimazione CO e 118 Ospedale Maggiore AUSL
city: Bologna
country: Italy
facility: UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL
Study officials:
affiliation: Azienda Unità Sanitaria Locale Bologna
name: Giovanni Gordini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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. doi: 10.55782/ane-2011-1848.
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.
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.
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.
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.
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.