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

NCT04530214 | Unknown

• 2 other identifiers: 2018PPRC302019-A01811-56
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Stress Reaction

Outcome Measures

Primary Outcomes (3)

• Occurrence of depression

  Screening for depression will be done using a validated self-report questionnaire, the Geriatric Depression Scale Short Version (GDS). We will use the threshold value of 10 (score \> or =) which corresponds to a very high probability of depression.

  12 months following surgery

• Occurrence of "psychosomatic death"

  The diagnosis of "psychosomatic death" will be made by a physician. There is no consensus on the diagnosis of this syndrome. However, a patient with "psychosomatic death" is likely to be hospitalized or followed up medically and will not be able to respond to the investigator's request for a telephone interview.

  12 months following surgery

• Occurrence of death

  Vital status will be collected from the participant's family or referring physician or at the birth \& death record service (of the participant's town)

  12 months following surgery

Secondary Outcomes (16)

• Evolution of heart rate variability between enrollment and Visit 1

  Between enrollment and Visit 1 (45-60 days following surgery)

• Evolution of perceived stress level between enrollment and Visit 1

  Between enrollment and Visit 1 (45-60 days following surgery)

• Evolution of anxiety level between enrollment and Visit 1

  Between enrollment and Visit 1 (45-60 days following surgery)

• Evolution of post-traumatic stress disorder severity level between enrollment and Visit 1

  Between enrollment and Visit 1 (45-60 days following surgery)

• Evolution of quality of life between enrollment and Visit 1

  Between enrollment and Visit 1 (45-60 days following surgery)

Interventions

Blood collection OTHER

Blood collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)

Saliva collection OTHER

Saliva collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)

Electrocardiography (ECG) OTHER

Electrocardiography (ECG) at enrollment (24-72h following surgery) and at Visit 1 (45-60 days following surgery) to assess heart rate variability

Questionnaires BEHAVIORAL

Mental health assessment through questionnaires at enrollment (24-72h following surgery), at Visit 1 (45-60 days following surgery), at Visit 2 (7 months following surgery) and at Visit 3 (12 months following surgery)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the emergency room for a fracture of the upper end of the femur.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (4)

CHU Pellegrin

Bordeaux, 33000, France

NOT YET RECRUITING

Hôpital d'Instruction des Armées Percy

Clamart, 92140, France

NOT YET RECRUITING

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, 94163, France

NOT YET RECRUITING

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, 83800, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and saliva samples

MeSH Terms

Conditions

Fractures, Stress

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Anaïs DUFFAUD

CONTACT

178651315; anais.duffaud@intradef.gouv.fr

Study Design

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

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: November 4, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

FR (4)