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

NCT07342023 | Not Yet Recruiting

• 2 other identifiers: AOI 2025 SAPIN (BACHUS)2025-A02166-43
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment until the end of hospitalization, for a maximum duration of 28 days

Secondary Outcomes (2)

• Clinical performance according to patient characteristics: stratification

  From enrollment until the end of hospitalization, for a maximum duration of 28 days.

• Analysis of the organizational impact

  From enrollment until the end of hospitalization, for a maximum duration of 28 days

Study Arms (1)

One arm

EXPERIMENTAL

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.

Diagnostic Test: blood sampling

Interventions

blood sampling 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.

One arm

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CH Riom: collaborator
• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Ch de Riom

Riom, France

Location

MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Clément Lahaye

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33473751195; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)