Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04074850 |
| Other study ID # |
S62848 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
November 3, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
A better understanding of the injury patterns, injury severity, risk profiles, consequences
and impact of Traumatic Brain Injury (TBI) in the elderly population is necessary due to the
increasing incidence and prevalence of TBI in this population and its high economic impact on
society. Therefore, this study aims at describing the long-term consequences of TBI. In order
to achieve that goal, injury patterns, injury severity and risk profiles for TBI in the
elderly will be mapped. Moreover, a retrospective assessment of brain damage, co-morbidities
and post-traumatic history, and a prospective assessment of cognitive functions and quality
of life in a 20 years range after TBI will be performed. Finally, a statistical correlation
of TBI and different types of neurodegenerative diseases, and an economic costs analysis will
be done. All the obtained results will be used to develop a new prognostic tool for the
course of the outcomes of TBI in the elderly population.
Description:
A database of over 1200 patients will be created by the retrospective capture of the
following data in UZ Leuven database:
Injury mechanisms data:
In order to create a map of injury patterns, severity and criteria that allow for identifying
which accident circumstances ageing adults should reasonably be protected against, including
a kinematics tolerance curve for the elderly brain that can be used for protection purposes,
a retrospective analysis of data related to injury mechanisms, registered in the patient's
clinical records, will be performed for the cohort of patients.
Clinical data:
Data regarding the following parameters will be retrospectively collected in UZ Leuven
database for the studty cohort: age, sex, cause of injury, GCS, pupillary reactivity,
hypoxia, hypotension, hypothermia and Marshall CT classification at the time of admission.
Moreover, Glasgow Outcome Scale (GOSE) at 6 months after the accident, obtained in the
context of routine clinical practice, will also be considered.
These data will be correlated with the results obtained during the injury patterns, injury
severity and risk profiles mapping, in order to better understand what accident types are
most risky to eventually result in poor outcome.
Economic data:
In order to know what is the economic impact that TBI in the elderly has on society, hospital
costs for the clinical management in the study cohort will be retrospectively extracted from
the financial database of UZ Leuven.
All these data will be anonymized and no informed consent will be used in this part of the
study.
Current status assessment:
In this part of the project, all the patients ≥65 years old admitted to UZ Leuven due to TBI
between 1999 and 2019, and fulfilling previously explained inclusion and exclusion criteria,
will be contacted through a phone call by an investigator of this project, and offered to
participate in the study.
UZ Leuven administration (MIR) has access to a central national database, so the list of
patients will be screened prior to the start of the phone calls in order to exclude the
patients that are deceased and avoid calling them.
The informed consent form will be distributed among the patients via post or e-mail,
depending on their preferences. Patients will have to send the signed informed consent form
back to the researchers via post or e-mail in order to be assessed.
Once the researchers receive the signed informed consent form, patients will be called again
and they will have the cognitive and quality of life evaluation, which consists of:
-Cognitive evaluation: the Telephone Interview for Cognitive Status (TICS) tool will be used
to study cognitive functions in the cohort. It is a 11-items screening test for cognitive
functions, including word list memory, orientation, attention, repetition, conceptual
knowledge and nonverbal praxis. The necessary time to perform it is 10 min or less.
Moreover, the patients' level of education will be asked, registered and correlated with
clinical data, cognitive functions and quality of life outcomes.
- Sleep quality assessment: the sleep quality in our cohort will be assessed using the
Pittsburgh Sleep Quality Index.
- Quality of life evaluation: the Quality of Life after Brain Injury (QOLIBRI) tool will
be used to assess the quality of life in the cohort. It is a 37-item questionnaire with
six subscales that measure quality of life in the domains of cognition, self, daily life
and autonomy, social relationships, emotions, and physical problems. The approximate
time necessary to fill this questionnaire in is 10 min.
Once the investigators get the signed informed consent, injury mechanisms data, clinical data
and clinical-care related economic data will be collected from UZ Leuven database and
correlated to the cognitive, sleep quality and quality of life outcomes. Also, for all the
patients in the study cohort that live in the surrounding areas of Leuven and have UZ Leuven
as a reference hospital after TBI, a retrospective revision of the clinical records will be
performed for the identification of diagnosis for neurodegenerative diseases that developed
after TBI.
Based on previous statistical figures, the investigators expect to have a cohort of over 500
patients for this current status assessment.
