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Completed

NCT Number: NCT03767712

Trauma as a Trigger for Autoimmunity

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.

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Key information

Conditions

Autoimmunity Autoimmune Diseases Immune System Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.

Diagnostic Test

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)

Primary outcomes

  1. 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

  1. Change in ANA

    Time frame: 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

    Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy)

  2. Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)

    Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

    serum level of Anti-dsDNA (U/ml)

  3. Change in Antibody level against Anti-Cardiolipin

    Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

    serum level of Anti-Cardiolipin (U/ml)

  4. Change in Antibody level against complement component C1q (Anti-C1q)

    Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

    serum level of C1q (U/ml)

  5. Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)

    Time frame: 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)

  6. Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells

    Time frame: 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)

  7. 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)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: TATA

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Dec 7, 2018
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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