Spinal cord injury-induced secondary immune depression (SCI-IDS) - a prospective and multicenter study
- Conditions
- T09.3T08.0Injury of spinal cord, level unspecified
- Registration Number
- DRKS00000122
- Lead Sponsor
- Charité Universitätsmedizin Berlin, CCM, Klinik für Neurologie und Abteilung für Experimentelle Neurologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 117
• Patients suffering from an isolated traumatic spinal cord injury (ASIA A-D), surgical stabilization scheduled, lesion can include more than 1 segment
• Or patients suffering from acute isolated spinal fracture without neurological abnormality (ASIA E), surgical stabilization scheduled, lesion can include more than 1 segment
• Legal age of the patient
• Documented informed consent of the patient
• Non-traumatic spinal cord injury
• 2 or more spinal cord lesions definable one from another
• Severe Polytrauma
• Additional serious traumatic brain injury (TBI)
• Neoplasia and/or antineoplastic therapy
• Rheumatic diseases / collagenosis / vasculitis
• Other autoimmune diseases
• Pre-existing acute/chronic infection
• Pre-existing systemic steroid treatment
• Severe alcohol or drug addiction
• Pregnancy, lactation
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parameters of venous blood samples - Immunephenotyping: HLA-DR-expression on monocytes.
- Secondary Outcome Measures
Name Time Method Parameters of venous blood samples - immunephenotyping and blood count: Lymphocyte subpopulation: B-, T- and NK-cells; T-cell subpopulation: CD3, CD4, CD8; T-cell activation: HLA-DR, LFA-1, CD28, CD57.<br>Soluble mediators/cytokines: PCT, LBP, Il-6, Il-10; ConA-induced T-lymphocyte cytokine production: TNF-alpha, IL-10 after 24h.<br>CRFs: current mediation, infectious diseases (pneumonia, UTI).