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临床试验/NCT07342023
NCT07342023尚未招募不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 770 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
770
试验地点
1
主要终点
Determination of the specificity, sensitivity, positive predictive value, and negative predictive value of the personalized biological strategy

研究概览

简要总结

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.).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: blood sampling (Diagnostic Test)

结局指标

主要结局

Determination of the specificity, sensitivity, positive predictive value, and negative predictive value of the personalized biological strategy

时间窗: 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.

次要结局

  • 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)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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