UCH-L1 GFAP
Othermeasurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury
NCT Number: NCT05885529
The goal of this observational study is to evaluate the performance of UCH-L1 and GFAP combined in patients with a mild traumatic brain injury. The main question :
• Does the combination of UCH-L1 and GFAP can exclude brain injuries detected with CT scan in the first twelve hours after a mild traumatic brain injury?
Participants will do the exams planed in routine care and :
* during the expected blood sampling an additional blood sample will be done, * seven days after the discharge a call will be done by the investigator.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Centre Hospitalier Universitaire d'Angers, Angers, France
Main study
The main study includes subjects presenting to the emergency department within 12 hours of mild traumatic brain injury with an intermediate risk of clinical worsening or intracranial lesions.
The participants have at least one of the following characteristics, as defined in the French recommendations
The study includes clinical sites in France and Monaco. Participants have a blood sample and a brain scan as part of the care. The participation of subjects in the study will not influence their treatment.
Ancillary study The ancillary study uses qualitative research methodology to assess acceptance by physicians and patients of a biological test rather than a CT scan to exclude intracranial complication after mild traumatic brain injury.
The study will takes place in the emergency department of the Nice University Hospital Center (CHU of Nice). It will include 30 subjects: 15 subjects presenting to the emergency room for mild traumatic brain injury and included in the main protocol and 15 prescribing emergency physicians.
The participation of subjects in the study will not influence their treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury
Time frame: during the first 12 hours
Percentage of intracranial lesion excluded by UCH-L1 and GFAP combined, versus the CT scan, within the first 12 hours following a MTBI
Time frame: during the first 12 hours
Percentage of intracranial bleeding excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a MTBI
Time frame: during the first 12 hours with a focus every 3 hours
Percentage of intracranial lesion excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a MTBI .
Time frame: during the first 12 hours with a focus every 3 hours
Percentage of intracranial complication identified by UCH-L1 and GFAP, alone or in combination, versus PS100b within the first 12 hours following a MTBI .
Time frame: day 7
Variation of resource consumption by the use of UCH-L1 and GFAP
Time frame: during the first 7 days
Percentage of complications avoided by the use of UCH-L1 and GFAP, alone or combined.
Time frame: Day 1
Acceptability by a semi-directed interview of a new strategy integrating the use of biomarkers for the management of MTBI by patients and investigators
Contact information is provided by the study sponsor or research team.
Nicolas RIJO, CRA
CONTACT
97 98 99 00 ext. +377
Yann-Erick CLAESSENS, MD-PhD
CONTACT
97 98 99 00 ext. +377
Centre Hospitalier Princesse Grace
Other
Added Value, Performance and Acceptance of the "GFAP-UCH-L1" Pair in the Evaluation of Subjects with Mild Traumatic Brain Injury (MTBI) At Intermediate Risk of Complications
Acronym: GUEST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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