- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03028376
Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients (PreTBI II)
S100B and Glial Fibrillary Acidic Protein (GFAP) in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in Patients Suffering Moderate Traumatic Brain Injury (TBI)
The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and GFAP measurements in prediction of need for neurosurgical observation and/or intervention in moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will benefit from neuro surgical expertise in specialized departments and thereby possibly better patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption and streamline patient courses by predicting the presence of neurotrauma.
Hypotheses:
- A prehospital serum S100B level > 0,10 microgram/L and expectedly above a certain and currently unknown cut-off value indicates the need for neurosurgical observation and/or intervention in moderate TBI patients.
- A prehospital serum GFAP level above a certain and currently unknown cut-off value can significantly predict a need for urgent neurosurgical observation and/or intervention in moderate TBI patients.
- Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict a need for urgent neurosurgical observation and/or intervention.
- Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict hospital course and outcome of patients with moderate TBI.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Aarhus N, 덴마크, 8200
- Prehospital Emergency Medical Services, Central Denmark Region
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients presenting with Glasgow Coma Score (GCS) GCS 9-13 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state.
Exclusion Criteria:
- Patients <18 years, GCS <9, >6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Moderate TBI patients
GCS 9-13
|
운송 중에 외상 환자에게 일상적으로 삽입되는 말초 정맥 카테터의 혈액 샘플링
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Sensitivity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
Specificity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
Positive predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
Negative predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Sensitivity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
Specificity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
Positive predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
Negative predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
"호의적인 신경학적 결과"에 대한 예/아니오 질문으로 측정된 이진 결과와 관련하여 병원 전과 병원 내 se-S100B, se-GFAP 및 se-NSE 값 조합 사이의 바이오마커 역학은 호의적/비호의적 선택
기간: 외상 후 1년 이내의 사건과 관련하여
|
외상 후 1년 이내의 사건과 관련하여
|
|
Sensitivity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
기간: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
Specificity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
기간: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
Positive predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
기간: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
Negative predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
기간: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
기간: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
기간: in relation to event within 1 year of trauma
|
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
|
in relation to event within 1 year of trauma
|
Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
기간: in relation to event within 1 year of trauma
|
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
|
in relation to event within 1 year of trauma
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
외상성 뇌 손상에 대한 임상 시험
-
The Second Hospital of Qinhuangdao완전한
-
University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
-
National Health Service, United KingdomUniversity of Bradford완전한
채혈에 대한 임상 시험
-
University Hospital, Rouen아직 모집하지 않음
-
Haydarpasa Numune Training and Research Hospital완전한
-
The University of Texas Health Science Center,...National Center for Advancing Translational Sciences (NCATS)아직 모집하지 않음
-
Ischemia Care LLC완전한허혈성 뇌졸중 | 심방세동 | 혈전성 뇌졸중 | 일시적인 허혈 발작 | 심장색전성 뇌졸중 | 뇌저동맥의 뇌졸중 | 일시적인 뇌혈관 사건미국
-
Bedford Hospital NHS TrustAnglia Ruskin University알려지지 않은