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

January 6, 2026 updated by: University Hospital, Clermont-Ferrand

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.).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

770

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance according to patient characteristics: stratification
Time Frame: 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.
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
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
From enrollment until the end of hospitalization, for a maximum duration of 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

CH Riom

Investigators

  • Principal Investigator: Clément Lahaye, CHU de Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI 2025 SAPIN (BACHUS)
  • 2025-A02166-43 (Other Identifier: 2025-A02166-43)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fallers Aged 60 Years and Older

Clinical Trials on blood sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe