Trauma as a Trigger for Autoimmunity

NCT03767712 | Completed

• 1 other identifier: 2016-00895, me16Potlukova
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmunity

Keywords

trauma; immunological reaction to trauma; pertrochanteric femoral fracture; antinuclear antibodies; activation of innate immunity; adaptive immunity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in ANA

  6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

• 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 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

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• pertrochanteric femoral fracture (≤7 days)
• planned gamma nail osteosynthesis
• ability to give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples of each subject in a form of biobank (TATA-Biobank) in order to allow future analyses (e.g. emerging biomarkers in relation to trauma).

MeSH Terms

Conditions

Autoimmune Diseases; Wounds and Injuries

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Eliska Potlukova, PhD

  Klinik für Innere Medizin, Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 7, 2018
• Study Start: July 4, 2016
• Primary Completion: December 23, 2019
• Study Completion: January 31, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

CH (1)