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Predictive Elements of Trauma and Its After-effects: Importance of the Quality of Neurobiological Response to Stress (LIFT-UP)

D

Direction Centrale du Service de Santé des Armées

Status

Enrolling

Conditions

Stress Reaction

Treatments

Other: Electrocardiography (ECG)
Behavioral: Questionnaires
Other: Blood collection
Other: Saliva collection

Study type

Observational

Funder types

Other

Identifiers

NCT04530214
2018PPRC30
2019-A01811-56 (Other Identifier)

Details and patient eligibility

About

The neurobiological response to stress is an adaptive response allowing us to cope with the multiple aggressions of daily life. This response orchestrates the body's systemic reaction. The intensity of response to stress can modify the body's functioning, which implies a variety of fields where biomarkers may be isolated: immunity, psychology, neurophysiology, integrative physiology. When stress is too intense or prolonged, response to stress may become misfitted and deleterious.

This study is based on the hypothesis that a severe physical or psychological trauma is associated with an intense and misfitted stress that is responsible from an undue immuno-inflammatory activation (through sympathetic activation). The result is a subinvasive state of systemic and tissue inflammation (low-noise inflammation), responsible for the mid-term deleterious consequences of the traumatic event.

The objective of this study is to understand how the dysregulation of intense stress simultaneously generates an initial pathological state and an alteration of mid-term evolution (which is considered as a poor prognosis and/or as responsible for after-effects).

The investigators wish to identify relevant biomarkers of the mechanisms activated during intense stress and influencing the immuno-inflammatory and epigenetic spheres with deleterious consequences on physiological and psychological functions.

Enrollment

130 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Fracture of the upper end of the femur
  • Cognitive state allowing the understanding of questionnaires

Exclusion criteria

  • Traumatic Brain Injury
  • Chronic inflammatory or immune pathologies
  • On anticoagulants
  • On neuroleptic or antidepressant treatment
  • Pathology or health condition not allowing 1-year survival

Trial contacts and locations

4

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Central trial contact

Anaïs DUFFAUD

Data sourced from clinicaltrials.gov

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