The purpose of the this study is to evaluate the prognostic capabilities of biomarkers in CSF in patients with SCI.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The concentrations of Neuron Specific Enolase, Glial Fibrillary Acidic
Protein, S-100ß, Neurofilament Protein, Tau and Myelin Basic Protein in CSF in
patients with SCI.
2. Evaluation of the ASIA classification system and SCIM of all patients at
different times
3. The relation between the concentrations of Neuron Specific Enolase, Glial
Fibrillary Acidic Protein, S-100ß, Neurofilament Protein, Tau and Myelin Basic
Protein in CSF and the ASIA impairment scale after 12 months in SCI patients
Secondary outcome
is not applicable
Background summary
Magnetic 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. Besides spinal cord imaging there is a method for the
assesment of spinal cord injury using biomarkers in cerebrospinal fluid (CSF).
Study objective
The purpose of the this study is to evaluate the prognostic capabilities of
biomarkers in CSF in patients with SCI.
Study design
In this prospective cohort study the data are collected of all patients with
SCI. The following descriptive data are collected: mechanism of injury,
clinical data and radiological findings using conventional radiographs and
computed tomography. Within 24 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 CSF sample will be taken. Throughout the rehabilitation and
during admission the SCIM (Spinal Cord Impairment Measurement) and the ASIA
(American Spinal Injury Association) classification system will be evaluated.
This will be evaluated until 12 months after the initial trauma.
Study burden and risks
The spinal puncture will be performed during the operation. Patients will be
completely sedated. Therefore, the burden of this spinal puncture is restricted
to a minimum. In our previous study (2007/282), no complications were reported.
It is the opinion of this research group that the possible advantages of DWI
and biomarkers for future patients with SCI outweigh the minimal disadvantages
of this diagnostic test.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Blunt spinal cord injury (Neurological level of injury C2-Th10)
Neurological deficit
Primarily refererred
Glasgow Coma Scale >= 10 (E4+V6)
Exclusion criteria
penetrating spinal cord injury
normal neurologic examination
non-traumatic spinal cord injury
traumatic brain injury
pre-existent neurological disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 1381 |
| CCMO | NL31985.091.10 |