Trauma as a Trigger for Autoimmunity

NCT ID: NCT03767712

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-04

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Autoimmunity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eliska Potlukova, PhD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Innere Medizin, Universitätsspital Basel

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2016-00895, me16Potlukova

Identifier Type: -

Identifier Source: org_study_id

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