Trauma as a Trigger for Autoimmunity - a Single Centre Observational Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in ANA
Study Overview
Brief Summary
To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on the development of autoimmunity.
Detailed Description
This project represents a unique study of the influence of trauma on the immune system. It addresses the question whether an excess of apoptotic/necrotic cells can induce an at least transient autoimmune phenomena in humans. If the hypothesis of a transient induction of autoimmunity by trauma proves to be correct, this study will provide a novel insight into the pathogenesis of autoimmune diseases.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pertrochanteric femoral fracture (≤7 days)
- •planned gamma nail osteosynthesis
- •ability to give written informed consent
Exclusion Criteria
- •Severe hepatic and renal failure
- •current active oncological disease
- •current immunosuppressive or biological therapy
- •known systemic autoimmune disease
- •foreseeable lack of complete follow-up (e.g. due to generally poor health)
- •cognitive impairment (delirium, dementia, alteration of consciousness)
- •insufficient knowledge of project language
- •pregnancy
Outcomes
Primary Outcomes
Change in ANA
Time Frame: Preoperative (1-2 days preoperative) and 12 weeks postoperative
Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy = indirect immunofluorescence on a Hep-2 cell line). In order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used (NOVA View, INOVA Diagnostics
Secondary Outcomes
- Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)(Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative)
- Change in Antibody level against Anti-Cardiolipin(Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative)
- Change in ANA(6 weeks postoperative and 12 weeks postoperative and 12 months postoperative)
- Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)(Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative)
- Change in Antibody level against complement component C1q (Anti-C1q)(Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative)
- Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)(Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative)
- Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells(Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative)