Trauma as a Trigger for Autoimmunity

Autoimmunity Clinical Trial

— TATA  

Official title:

Trauma as a Trigger for Autoimmunity - a Single Centre Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767712
• Other study ID #: 2016-00895, me16Potlukova
• Status: Completed
• Start date: July 4, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoimmunity

Intervention

Diagnostic Test:
• Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.
To analyse whether patients with pertrochanteric femoral fracture with consecutive gamma-nailing develop any laboratory signs of transient autoimmunity (comparison of the levels of ANA; in order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used)

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ANA	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	Preoperative (1-2 days preoperative) and 12 weeks postoperative
Secondary	Change in ANA	Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy)	6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Secondary	Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)	serum level of Anti-dsDNA (U/ml)	Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Secondary	Change in Antibody level against Anti-Cardiolipin	serum level of Anti-Cardiolipin (U/ml)	Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Secondary	Change in Antibody level against complement component C1q (Anti-C1q)	serum level of C1q (U/ml)	Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Secondary	Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)	serum level of Anti-SSA/Ro (U/ml)	Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Secondary	Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells	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)	Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative
Secondary	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 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