Contribution of GFAP and UCH-L1 Assays in Whole Blood to Optimizing Personalized Care for "Repeated Fallers" Hospitalized in Geriatric Wards
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling.
- Who it may be relevant to
- Registry conditions: Fallers Aged 60 Years and Older, Biomarkers / Blood, Intracranial Bleeding. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test blood 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, pref
Primary outcome measures
- Determination of the specificity, sensitivity, positive predictive value, and negative predictive value of the personalized biological strategy [Time frame: From enrollment until the end of hospitalization, for a maximum duration of 28 days]
Secondary outcome measures (2)
- Clinical performance according to patient characteristics: stratification [Time frame: From enrollment until the end of hospitalization, for a maximum duration of 28 days.]
- Analysis of the organizational impact [Time frame: From enrollment until the end of hospitalization, for a maximum duration of 28 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Ch de Riom — Riom
Identifiers
NCT: NCT07342023 · AOI 2025 SAPIN (BACHUS) · 2025-A02166-43