Contribution of GFAP and UCH-L1 Assays in Whole Blood to Optimizing Personalized Care for "Repeated Fallers" Hospitalized in Geriatric Wards

NCT ID: NCT07342023

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 770 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-08-31

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.).

Conditions

Fallers Aged 60 Years and Older; Biomarkers / Blood; Intracranial Bleeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

One arm

The BACHUS study, a prospective single-center 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.

Group Type: EXPERIMENTAL

blood sampling

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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, 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.

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CH Riom

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clément Lahaye

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Locations

Ch de Riom

Riom, , France

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473751195

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

Other Identifiers

2025-A02166-43

Identifier Type: OTHER

Identifier Source: secondary_id

AOI 2025 SAPIN (BACHUS)

Identifier Type: -

Identifier Source: org_study_id