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.).
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
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
Single group
blood sampling
Diagnostic testPatients 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.
Determination of the specificity, sensitivity, positive predictive value, and negative predictive value of the personalized biological strategy
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.
Clinical performance according to patient characteristics: stratification
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
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
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University Hospital, Clermont-Ferrand
Lead sponsor
CH Riom
Collaborator
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