Clinical trial NCT03767712: Trauma as a Trigger for Autoimmunity
Official title: Trauma as a Trigger for Autoimmunity - a Single Centre Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmunity
Keywords: trauma
immunological reaction to trauma
pertrochanteric femoral fracture
antinuclear antibodies
activation of innate immunity
adaptive immunity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute pertrochanteric fracture in whom an operation (gamma-nail osteosynthesis) is planned at the University Hospital Basel.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ANA
timeFrame: Preoperative (1-2 days preoperative) and 12 weeks postoperative
Secondary outcomes:
measure: Change in ANA
timeFrame: 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
measure: Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)
timeFrame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
measure: Change in Antibody level against Anti-Cardiolipin
timeFrame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
measure: Change in Antibody level against complement component C1q (Anti-C1q)
timeFrame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
measure: Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)
timeFrame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
measure: Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells
timeFrame: Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative
measure: 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)
timeFrame: Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Klinik für Innere Medizin, Universitätsspital Basel
name: Eliska Potlukova, PhD
role: PRINCIPAL_INVESTIGATOR
References: