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The value of diffusion-weighted MR imaging and biomarkers in cerebrospinal fluid in acute spinal cord injury as predictors of outcome.


- candidate number3627
- NTR NumberNTR1381
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2008
- Secondary IDsUMCN-2008 UMCN St Radboud
- Public TitleThe value of diffusion-weighted MR imaging and biomarkers in cerebrospinal fluid in acute spinal cord injury as predictors of outcome.
- Scientific TitleThe value of diffusion-weighted MR imaging and biomarkers in cerebrospinal fluid in acute spinal cord injury as predictors of outcome.
- ACRONYMSPIDI Trial
- hypothesisProspective study determing whether MRI-Diffusion Weighted Imaging (DWI) and biomarkers in CSF have prognostic capabilities in patients with Spinal Cord Injury (SCI).
- Healt Condition(s) or Problem(s) studiedSpinal cord injury, Spinal Cord Injury, Spinal cord lesion , Biomarkers, Diffusion weighted imaging (DWI), Magnetic resonance imaging (MRI)
- Inclusion criteria1. Closed spinal cord injury
2. Associated neurologic deficit
3. Primarily referred to UMC St. Radboud
4. Glasgow Coma Scale of 15
- Exclusion criteria1. Penetrating spinal cord injury
2. Normal neurologic examination
3. Ischaemic spinal cord injury
4. Traumatic brain injury
5. Pre-existent neurological disorder
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2008
- planned closingdate1-feb-2013
- Target number of participants60
- InterventionsWithin 24 hour after the initial trauma all patients with SCI recieve a MRI and a DWI examination.
Within 72 hours after the initial trauma all patients with SCI will be operated on the cervical and/or thoracic spinal cord. During this operation a 3 ml cerebrospinal fluid (CSF) sample will be taken
- Primary outcome1. Size of the lesion (hemorrhage, edema, contusion) in the spinal cord measured in millimetres using MRI
2. Size of the lesion (hemorrhage, edema, contusion) in the spinal cord measured in millimetres using DWI
3. The values of Apparent Diffusion Coefficients (ADC) in the lesion and in normal spinal cord in 10-3 mm2/s measured using DWI
4. The concentrations of Neuron Specific Enolase, Glial Fibrillary Acidic Protein, S-100, Neurofilament Protein, Tau and Myelin Basic Protein in CSF in patients with SCI.
5. Evaluation of the ASIA classification system and SCIM of all patients at different times
- Secondary outcomeN/A
- Timepoints- MRI-DWI within 24 hours after the initial trauma
- A CSF sample within 72 hours after the initial trauma
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.H. Pouw
- CONTACT for SCIENTIFIC QUERIES M.H. Pouw
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
International Foundation for Research in Paraplegia
- PublicationsN/A
- Brief summaryMagnetic Resonance Imaging (MRI) is still the technique of choice for the evaluation of spinal cord injury (SCI). MRI however has limited succes as a prognostic tool.
Diffusion-weighted MRI (DWI) has been proposed as a method to evaluate the integrity of microstructural changes in the spinal cord. Besides spinal cord imaging there is a method for the assesment of spinal cord injury using biomarkers in cerebrospinal fluid (CSF).
- Main changes (audit trail)
- RECORD15-jul-2008 - 12-mrt-2010


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