The Use of GFAP and UCH-L1 Biomarkers in Clinical Practice for the Management of Mild Traumatic Brain Injury (BIO-TC-L)
Mild traumatic brain injury (mTBI) is a frequent reason for emergency department visits. Although most patients have a normal brain CT scan, this examination is still widely ordered, exposing patients to radiation, overloading imaging services and increasing care costs. The decision to perform a brain CT scan is usually based on validated clinical decision rules, such as the Canadian CT Head Rule (CCHR) or the New Orleans Criteria (NOC). However, several studies including a recent meta-analysis suggest significant CT overuse in the management of mTBI.
In recent years, biomarkers specific to brain injury mainly Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) have shown their ability to reliably rule out the presence of clinically significant intracranial injuries.
The combined use of GFAP and UCH-L1 has been recommended by the French Society of Anesthesia and Intensive Care Medicine (SFAR) and the French Society of Emergency Medicine (SFMU) in patients with mild traumatic brain injury at intermediate risk of intracranial bleeding, in order to limit the number of brain CT scans. Although prospective observational studies have evaluated the value of using these biomarkers, no study has evaluated their implementation in routine clinical practice.
연구 개요
상세 설명
The study will be conducted in the Emergency Department (ED) of Grenoble University Hospital.
The main objective of this prospective, single-center, observational study is therefore to analyze the use of GFAP and UCH-L1 biomarkers in routine clinical practice at Grenoble University Hospital to confirm their clinical utility and safety.
All adult patients presenting to the Grenoble Alpes University Hospital emergency department for mild traumatic brain injury will be enrolled and analyzed during the study period.
Data will be collected from electronic medical records. To assess patient's outcomes 1 month after their emergency department visit, a follow-up will telephone call will be conducted for the subgroup of patients who had a negative biomarker result without an initial CT scan.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Prudence MABIALA MAKELE, PhD
- 전화번호: 0033476766784
- 이메일: pmabialamakele@chu-grenoble.fr
연구 연락처 백업
- 이름: Nicolas SEGOND, MD PhD
- 전화번호: 0033476766784
- 이메일: NSegond@chu-grenoble.fr
연구 장소
-
-
Isere
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Grenoble, Isere, 프랑스
- Grenoble University Hospital
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연락하다:
- Prudence MABIALA MAKELE, PhD
- 전화번호: 0033476766784
- 이메일: pmabialamakele@chu-grenoble.fr
-
연락하다:
- Nicolas SEGONG, MD PhD
- 전화번호: 0033476766784
- 이메일: NSegond@chu-grenoble.fr
-
수석 연구원:
- Nicolas SEGOND, MD PhD
-
부수사관:
- Damien VIGLINO, MD PhD
-
부수사관:
- Dorra GUERGOUR, MD PhD
-
부수사관:
- Carole CHIRICA, MD
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adult patient admitted in the Emergency department of Grenoble University Hospital for mild traumatic brain injury over a 4-month enrollment period from the start of the study
설명
Inclusion Criteria:
- Patients over 18 years admitted to the emergency department of Grenoble University Hospital for mild traumatic brain injury over a 4-month enrollment period from the start of the study
Exclusion Criteria:
- Patients with penetrating head injury
- Patients with a Glasgow Coma Scale score between 3 and 12 on admission to the emergency department
- Patients unable to communicate or who do not speak French
- Persons covered by Articles L1121-6 and L1121-8 of the French Public Health Code (CSP) (persons deprived of liberty by administrative or judicial decision, unable to understand the protocol)
- Patients already enrolled in the study during a previous emergency department visit
- Patients not affiliated to the french social security system
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
All adult patients admitted in the Emergency Department for mild traumatic brain injury
All adult patients presenting to the Grenoble Alpes University Hospital emergency department for mild traumatic brain injury will be enrolled and analyzed during the study period |
To assess patient's outcomes 1 month after their emergency department visit, a follow-up will telephone call will be conducted for the subgroup of patients who had a negative biomarker result without an initial CT scan.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The proportion of patients who underwent GFAP and UCH-L1 testing, and in whom a brain CT scan was avoided following a negative result in accordance with current guidelines
기간: 1 month
|
The proportion of patients who underwent GFAP and UCH-L1 testing, and in whom a brain CT scan was avoided following a negative result in accordance with current guidelines |
1 month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of protocol deviations
기간: 24 hours
|
Proportion of protocol deviations (TBI wrongly classified as mild, Biomarkers wrongly measured, Biomarkers not measured when indicated, Brain CT scan wrongly performed, Brain CT scan not performed when indicated). |
24 hours
|
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Calculation of the time from emergency department arrival to biomarker ordering
기간: 24 hours
|
Calculation of the time from emergency department arrival to biomarker ordering (the time from biomarker ordering to result reporting). |
24 hours
|
|
Assess the safety of using brain biomarkers in routine clinical practice, based on the 1-month clinical outcome of patients who had a negative measurement without an initial CT scan
기간: 1 month
|
Proportion of patient who returned to the emergency department or to their general practitioner for a reason related to head trauma within one month of the initial visit. And proportion of CT scans showing a significant intracranial injury among those performed within the month |
1 month
|
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Evaluate the prognostic performance of brain biomarkers for ruling out intracranial injury, in the overall population and by age
기간: 1 month
|
Calculation of prognostic performance indicators (area under the curve, sensitivity, specificity, positive and negative predictive values) of brain biomarkers for ruling out intracranial injury, in the overall population and by age |
1 month
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Nicolas SEGOND, MD PhD, University Hospital, Grenoble
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 38RC26.0261
- IDRCB : 2026-A01713-48 (기타 식별자: CPP Est III (French Ethics Committees))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.
In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
IPD 공유 기간
At the time of publication
IPD 공유 액세스 기준
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. Moreover, In accordance with the French law n ° 2002-303 of March 4th, 2002
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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