Trauma as a Trigger for Autoimmunity

Completed

• Conditions: Autoimmunity

• Registration Number: NCT03767712
• Lead Sponsor: University Hospital, Basel, Switzerland

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 Timeline

• Study Start: 2016-07-04
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-07
• Primary Completion: 2019-12-23
• Study Completion: 2020-01-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in ANA	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 Outcome Measures

Name	Time	Method
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	serum level of Anti-dsDNA (U/ml)
Change in Antibody level against Anti-Cardiolipin	Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative	serum level of Anti-Cardiolipin (U/ml)
Change in ANA	6 weeks postoperative and 12 weeks postoperative and 12 months postoperative	Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy)
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 serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)
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	serum level of C1q (U/ml)
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	serum level of Anti-SSA/Ro (U/ml)
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	Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells (cells/ml)

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland