Evaluating outcomes in traumatic brain injury patients and their families
Assessment of the Feasibility of a Systematic Multidimensional Evaluation of the Outcome of Head Injury Patients and Their Families. A Single-center Pilot Cohort With Repeated Longitudinal Follow-up
Nantes University Hospital · NCT06194071
This study is trying to see how well we can track the recovery of people with traumatic brain injuries and their families over time to improve future care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 1 site (Nantes) |
| Trial ID | NCT06194071 on ClinicalTrials.gov |
What this trial studies
This study assesses the feasibility of collecting multidimensional evaluations of outcomes in patients with mild to severe traumatic brain injury (TBI) and their relatives. Participants will be evaluated at 6, 12, and 18 months post-injury through questionnaires and on-site visits. The study aims to identify factors that facilitate or hinder high-quality longitudinal follow-up, addressing potential biases in measurement and reporting. By understanding these factors, the research seeks to improve the quality of clinical evaluations in TBI.
Who should consider this trial
Good fit: Ideal candidates include adults with mild to severe TBI who have been admitted to the ICU or ER and have a CT-confirmed head injury.
Not a fit: Patients under 18 years of age or those without a relative or informal caregiver may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of TBI outcomes and improve care strategies for patients and their families.
How similar studies have performed: While similar studies have explored TBI outcomes, this specific multidimensional approach is novel and aims to address feasibility challenges.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients admitted to ICU with Glasgow score during initial car ≤ 14 and CT-confirmed head injury * Patients admitted to ER with Glasgow score during initial care ≤ 15 or concussion and CT-confirmed head injury or displaying clinicalsigns such as headaches or vomiting. Exclusion Criteria: * Patients under 18 years of age * Single patient, without relative or informal caregiver * Non-French-speaking patient * Refusal of consent * Patient under guardianship
Where this trial is running
Nantes
- CHU de Nantes — Nantes, France (RECRUITING)
Study contacts
- Study coordinator: Raphaël CINOTTI, Pr
- Email: raphael.cinotti@chu-nantes.fr
- Phone: +33(0)240084731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Brain Injury, Cohort, Pilot Study, Longitudinal follow-up