Trial document




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  DRKS00000122

Trial Description

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Title

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

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Trial Acronym

SCIentinel

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URL of the Trial

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Brief Summary in Lay Language

Recent studies demonstrated that a malfunction of the immune system (named immune depression) can be caused by injuries of the central nervous system. The depressed immune system is a relevant risk factor for the occurence of infections. Immune depression can also be caused by spinal cord injuries.
The study's scope is the characterization of the immune depression after injury to the spinal cord. This will be based on venous blood samples (for an analysis of immunological parameters) and physical examinations (with regard to the occurrence of infectious diseases).
Since the initial trial registration the following study amendments had been required: 1) An additional observational group has been added and the definitions of the observational groups have been changed. 2) The time schedule for observation has been re-structured. 3) The definitions of the primary endpoint and the secondary endpoints have been rendered more precisely. 4) A re-calculation of the sample size has been performed. 5) The inclusion and exclusion criteria have been revised.

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Brief Summary in Scientific Language

Infections, prevailingly pneumonia, and unrinary tract infections (UTI) are a leading cause of morbidity and mortality in patients with acute spinal cord injury (SCI). It has recently become clear thar SCI might increase susceptibility to infections by central nervous system (CNS)-specific mechanisms: CNS injury induces a disturbance of the normally well balanced interplay between the immune system and the CNS. As a result, also SCI may lead to secondary immunedeficiency (SCI-induced secondary immune depression syndrome, SCI-IDS) and thereby to infections.
After a first systematic quantitative characterization over time following experimental (Riegger et al., 2003, 2007) and human SCI within a pilot trial (Riegger et al., 2009) this study's aim is to investigate qualitative aspects referring to functional impairment of innate and specific immune functions following SCI.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000122
  •   2009/04/27
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  •   yes
  •   Approved
  •   EA1/001/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   T09.3 -  Injury of spinal cord, level unspecified
  •   T08.0 -  [generalization T08: Fracture of spine, level unspecified]
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Interventions/Observational Groups

  •   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 14, and 10 weeks post-trauma; neurological examination and concomitant injuries at inclusion; clinical documentation with regard to infections, current medication, re-operations at all assessment points.
  •   31 SCI-patients without corticosteroid treatment with a lesion level T5 or below. Trial related procedures: Venous blood samples at the following assessment points: <31h, 31-55h, day 7, day 14, and 10 weeks post-trauma; neurological examination and concomitant injuries at inclusion; clinical documentation with regard to infections, current medication, re-operations at all assessment points.
  •   39 patients with an acute isolated vertebral fracture without SCI (control group). Trial related procedures: Venous blood samples at the following assessment points: <31h, 31-55h, day 7, day 14, and 10 weeks post-trauma; neurological examination and concomitant injuries at inclusion; clinical documentation with regard to infections, current medication, re-operations at all assessment points.
  •   SCI-patients receiving methylprednisolone treatment are additionally enrolled (based on experiences from the clinical practice in the recruiting trial centres 10% of the screened SCI-patients, that means approximately 8 patients). Those patients are excluded from the 'per protocol' analysis. The evaluation will be performed in a casuistic manner and with descriptive methods in this group. Trial related procedures: Venous blood samples at the following assessment points: <31h, 31-55h, day 7, day 14, and 10 weeks post-trauma; neurological examination and concomitant injuries at inclusion; clinical documentation with regard to infections, current medication, re-operations at all assessment points.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Parameters of venous blood samples - Immunephenotyping: HLA-DR-expression on monocytes.

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Secondary Outcome

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).

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Countries of Recruitment

  •   Germany
  •   Canada
  •   Switzerland
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/08/21
  •   118
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Charité Universitätsmedizin Berlin, CCM, Klinik für Neurologie und Abteilung für Experimentelle Neurologie
    • Mr.  Prof. Dr. Dr.  Jan  Schwab 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Institute of Medical Immunology, Charité - Universitätsmedizin Berlin
    • Mr.  Dr.  Christian  Meisel 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, CCM, Klinik für Neurologie und Abteilung für Experimentelle Neurologie
    • Mr.  Prof. Dr. Dr.  Jan  Schwab 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, CCM, Klinik für Neurologie und Abteilung für Experimentelle Neurologie
    • Mr.  Prof. Dr. Dr.  Jan  Schwab 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Universitätsmedizin Berlin, CCM, NeuroCure Exzellenzcluster
    • NeuroCure 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Wings for Life Spinal Cord Research Foundation
    • Fürstenallee 4

    • A-5020  Salzburg

    • Austria
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Status

  •   Recruiting complete, follow-up complete
  •   2014/12/09
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* This entry means the parameter is not applicable or has not been set.