Trauma as a Trigger for Autoimmunity (TATA)

April 6, 2020 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Preoperative (1-2 days preoperative) and 12 weeks postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
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)
Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
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)
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)
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)
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)
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)
Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months 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
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)
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)
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)
Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eliska Potlukova, PhD, Klinik für Innere Medizin, Universitätsspital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-00895, me16Potlukova

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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