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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02166-43 | Other Identifier | 2025-A02166-43 |
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| Name | Class |
|---|---|
| CH Riom | UNKNOWN |
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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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | +33473751195 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Clément Lahaye | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch de Riom | Riom | France |
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| From enrollment until the end of hospitalization, for a maximum duration of 28 days. |
| 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 | From enrollment until the end of hospitalization, for a maximum duration of 28 days |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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