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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861808
• Other study ID #: CE 12105
• Secondary ID: RF-2010-2315118
• Status: Completed
• Phase: N/A
• First received: May 15, 2013
• Last updated: October 18, 2017
• Start date: August 24, 2013
• Est. completion date: August 31, 2017

Study information

• Verified date: April 2017
• Source: Azienda Usl di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 31, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Other:
• Lumbar puncture
The only intervention is the lumbar puncture on the patients to obtain a Cerebrospinal Fluid sample

Locations

Country	Name	City	State
Italy	UOC Rianimazione CO e 118 Ospedale Maggiore AUSL	Bologna
Italy	UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL	Bologna
Italy	Montecatone Rehabilitation Institute SpA	Imola	Bologna
Italy	Centro Interdipartimentale Ricerca Industriale Università degli Studi	Ozzano	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Usl di Bologna

Country where clinical trial is conducted

Italy, 

References & 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. Review. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Rossignol S, Schwab M, Schwartz M, Fehlings MG. Spinal cord injury: time to move? J Neurosci. 2007 Oct 31;27(44):11782-92. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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