Spinal cord injury-induced secondary immune depression (SCI-IDS) - a prospective and multicenter study -

Spinal cord injury-induced secondary immune depression (SCI-IDS) - a prospective and multicenter study - - SCIentinel

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00000122

Enrollment

118

Registered

2009-04-27

Start date

2011-08-21

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T09.3 T08.0

Interventions

Group 1: 48 SCI-patients without corticosteroid treatment with a lesion level T4 or above - Trial related procedures: Venous blood samples at the following assessment points: <31h, 31-55h, day 7, day

neurological examination and concomitant injuries at inclusion

clinical documentation with regard to infections, current medication, re-operations at all assessment points. Group 2: 31 SCI-patients without corticosteroid treatment with a lesion level T5 or below.

clinical documentation with regard to infections, current medication, re-operations at all assessment points. Group 3: 39 patients with an acute isolated vertebral fracture without SCI (control group)

clinical documentation with regard to infections, current medication, re-operations at all assessment points. Group 4: SCI-patients receiving methylprednisolone treatment are additionally enrolled (ba

neurological examination and concomitant injurie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Secondary

Measure	Time frame
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. Soluble mediators/cytokines: PCT, LBP, Il-6, Il-10; ConA-induced T-lymphocyte cytokine production: TNF-alpha, IL-10 after 24h. CRFs: current mediation, infectious diseases (pneumonia, UTI).	—

Primary

Measure	Time frame
Parameters of venous blood samples - Immunephenotyping: HLA-DR-expression on monocytes.	—

Countries

Canada, Germany, Switzerland

Contacts

Public ContactJan Schwab

Charité Universitätsmedizin Berlin, CCM, Klinik für Neurologie und Abteilung für Experimentelle Neurologie

jan.schwab@charite.de0049 30 450 560 293

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 22, 2026