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

Обзор

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.).

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Determination of the specificity, sensitivity, positive predictive value, and negative predictive value of the personalized biological strategy [Срок оценки: From enrollment until the end of hospitalization, for a maximum duration of 28 days]

Вторичные конечные точки (2)

• Clinical performance according to patient characteristics: stratification [Срок оценки: From enrollment until the end of hospitalization, for a maximum duration of 28 days.]
• Analysis of the organizational impact [Срок оценки: From enrollment until the end of hospitalization, for a maximum duration of 28 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Ch de Riom — Riom

Идентификаторы

NCT: NCT07342023 · AOI 2025 SAPIN (BACHUS) · 2025-A02166-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗