A41 A41.0 A41.9 J80 N17 K72.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: all patients with an Injury Severity Score (ISS) between = 16 and ISS < 42, primary allocation after accident, preclinical time < 120 min, regular completion of the first treatment in the emergency room, signed informed consent
Exclusion criteria
Exclusion criteria: all patients with an ISS 42, very poor prognosis/unfavourable prognosis (infaust prognosis) within first 24h after trauma, dementia or lacking cognitive abilities to participate the study (before trauma), patients with severe burn injuries, acute myocardial infarction, coronary bypass surgery, patients who are not primary allocated to the intensive care unit of the study center, tumor patients (chemotherapy,irradiation, HIV, Hepatitis A, B, C, HCV, CMV, immune suppressive drug medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical: Diagnosed complication after trauma (sepsis, septic shock, organ failure, multiple organ failure, death) Experimental: analysis of monocyte and regulatory t-cells function, daily in a time course of 10 days after trauma + determination of the cytokine profile in serum. Monocytic functionality is evaluated by whole blood stimulation with lipopolysaccharide and subsequent detemination of cytokines in the supernatant (TNF-a, IL-1ß and IL-10) by ELISA method. Phagocytosis-activity of monocytes is determined by incubation of blood samples with FITC-stained E.coli (opsonized)-solution and subsequent flow cytometric analysis. Determinatio of T-cell function is performed by stimulation with ConA and subsequent measurement of cytokines (IFN-?, IL-2, IL-4 und IL-10) in the supernatant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical: Diagnosed complication after trauma (sepsis, septic shock, organ failure, multiple organ failure, death) Experimental: analysis of the regulatory activity of t-regulatory cells. 1. Culture flasks are pre-coated with monoclonal anti-CD3 antibody. One part of CD4+ cells contains Tregs, another part of CD4+ cells is depleted from Tregs (CD4+ und CD4+CD25+CD127dim/-) by using microbeads. Both samples + soluble monoclonal anti-CD28 are added to the pre-coated or uncoated control plates. Experiments with control antibodies are also performed. After 3 days, the supernatant is collected and the cytokine profile will be analyzed (IFN-?, IL-2, IL-4 und IL-10). Here, we analyze the contribution of Tregs to the induction of T-helper cells (type 2, Th2) in dependence on complication development after trauma. 2.By using neutralizing anti-Human IL-10-antibody, on the one hand the IL-10-dependent maturation of Tregs will be analyzed and on the other hand Tregs-produced IL-10 neutralized. Thereby, the IL-10-driven Th2-induction can be inhibited. For this analysis, the identical experiment design as described above will be used and IL-10 antibody as well as control antibody will be added to the samples in different flasks. The same parameter as described above will be evaluated. Here, the role of IL-10 in Tregs-induction and subsequent Th2 induction will be clarified. | — |
Countries
Germany
Contacts
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie Klinik der J W Goethe-Universität