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Spinal Cord InjuriesNCT01861808

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

A study testing Lumbar puncture in people with Spinal Cord Injuries, run by Azienda Usl di Bologna at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Lumbar puncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesItaly
Study dates
24 Aug 2013to 31 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • UOC Rianimazione CO e 118 Ospedale Maggiore AUSL

    Bologna, 40133

  • UOSD Chirurgia Vertebrale di Urgenza e del Trauma Ospedale Maggiore AUSL

    Bologna, 40133

  • Montecatone Rehabilitation Institute SpA

    Imola, Bologna, 40026

  • Centro Interdipartimentale Ricerca Industriale Università degli Studi

    Ozzano Monferrato, Bologna, 40064

Other trials in Italy

About this study

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

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.

Being tested
Lumbar puncture
Keywords
Spinal Cord Injuries, Cerebrospinal Fluid
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumbar punctureOther

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

Study groups in NCT01861808
Study groupRoleWhat they receive
lumbar punctureOtherThat's not really an arm label because the only intervention on the patients is the lumbar puncture
Receives: Other: Lumbar puncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2013 (estimated)
  2. Study start24 Aug 2013
  3. Primary completion1 Sep 2016
  4. Study completion31 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01861808
Sponsor's protocol ID
CE 12105
Other IDs
RF-2010-2315118
Status last verified
Apr 2017
First submitted
15 May 2013
Last updated
19 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 11586111

  • 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.

    PubMed 21559420

  • 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.

    PubMed 20038240

  • 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.

    PubMed 21175377

  • 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.

    PubMed 21731081

  • 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.

    PubMed 21394541

  • 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.

    PubMed 17978014

  • 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.

    PubMed 11805601

  • 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.

    PubMed 19061765

  • 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.

    PubMed 20130419

Questions about this trial

What is this clinical trial studying?

A study testing Lumbar puncture in people with Spinal Cord Injuries, run by Azienda Usl di Bologna at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Creation of a model which analyze relationship among laboratory investigations and primary lesion, secondary damage and functional impairment (time frame: Three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01861808, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.

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