Biomarkers / Blood, Fallers Aged 60 Years and Older, Intracranial Bleeding
Conditions
Brief summary
The BACHUS study focuses on a population of patients aged 75 years and older who are hospitalized after recurrent falls. The objective is to evaluate the performance of an innovative, personalized biological screening strategy to detect intracranial hemorrhages, as an alternative to brain CT scanning, which is often difficult to access within the required time frame in elderly patients. Patients included in the study will undergo two blood measurements of the biomarkers GFAP and UCH-L1 performed on whole blood using a portable device such as the i-Stat Alinity. The first measurement will be performed within 72 hours of admission in order to establish an individual baseline value, given the impossibility of relying on average reference values in this population, which is subject to variability in biomarker levels due to confounding factors. In the event of a new fall during hospitalization, and when a brain CT scan is deemed necessary by the referring physician, a second measurement will be performed within the time window recommended by the French National Authority for Health (HAS) (6 to 12 hours after the fall), ideally before the CT scan. Apart from the addition of this blood sample, the study will not modify usual patient management, with the decision to perform a CT scan remaining at the clinician's discretion. The primary endpoint is the diagnostic performance of this personalized strategy (sensitivity, specificity, predictive values) compared with brain CT scanning, which remains the reference standard. The results will make it possible to estimate the number of CT scans that could be avoided. Secondary endpoints will allow further refinement of the analysis according to patient profile (age, sex, cognitive status, anticoagulant therapy, nutritional status, etc.).
Interventions
DIAGNOSTIC_TESTblood sampling
Patients included in the study will undergo two blood measurements of the biomarkers GFAP and UCH-L1 performed on whole blood using a portable device such as the i-Stat Alinity®. The first measurement will be performed within 72 hours of admission to establish an individual baseline value. After a fall with confirmed or suspected head trauma, when a brain CT scan is deemed necessary by the referring physician, a new measurement of GFAP and UCH-L1 biomarkers will be performed on whole blood, preferably before transfer to the CT scanner, ideally between 6 and 12 hours after the fall according to HAS recommendations, followed by the brain CT scan to detect any intracranial bleeding.
Sponsors
CH Riom
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients aged 75 years and older, cared for in the short-stay geriatric unit at Guy Thomas Hospital in Riom * Recurrent fallers (more than one fall per week) * Informed consent from the patient or their designated representative for patients unable to write but capable of understanding and consenting to participate in the study * Enrollment in a Social Security health insurance scheme
Exclusion criteria
* Fall occurring before the reference biomarker measurement * Presence of an intracranial hemorrhage confirmed by CT scan at admission * Ischemic or hemorrhagic stroke * Inability to perform the two blood samples required by the protocol due to very limited venous access * End-of-life situation * Adults under legal protection (guardianship, curatorship, deprivation of liberty, or judicial protection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the specificity, sensitivity, positive predictive value, and negative predictive value of the personalized biological strategy | From enrollment until the end of hospitalization, for a maximum duration of 28 days | Establishment of the clinical performance of a personalized biological strategy based on the combined measurement of the biomarkers GFAP and UCH-L1 in whole blood for the detection of intracranial hemorrhages in hospitalized patients aged 75 years and older with recurrent falls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance according to patient characteristics: stratification | From enrollment until the end of hospitalization, for a maximum duration of 28 days. | Determination of the clinical performance of the personalized biological strategy according to the following criteria: sex, age group (75-85 years; 85-95 years; over 95 years), cognitive impairment, presence of anticoagulant therapy, nutritional status, renal impairment, fall-risk profile, or characteristics of intracranial hemorrhages. |
| Analysis of the organizational impact | From enrollment until the end of hospitalization, for a maximum duration of 28 days | Estimation of the number of negative brain CT scans that could be avoided using the personalized biological strategy, compared with the conventional CT-based strategy |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed