Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients (PreTBI II)
2019年4月23日 更新者：University of Aarhus
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.
調査の概要
研究の種類
観察的
入学 (実際)
22
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Aarhus N、デンマーク、8200
- Prehospital Emergency Medical Services, Central Denmark Region
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～100年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance or anaesthetist-staffed critical care team dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark Region.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Moderate TBI patients
GCS 9-13
|
輸送中に外傷患者に日常的に挿入される末梢静脈カテーテルからの採血
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
「好ましい神経学的転帰」のはい/いいえの質問によって測定されたバイナリ結果に関連するse-S100B、se-GFAP、およびse-NSE値の病院前と院内の組み合わせ間のバイオマーカーのダイナミクスは、好ましい/好ましくないを選択します
時間枠：トラウマから1年以内の出来事に関して
|
トラウマから1年以内の出来事に関して
|
|
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年2月15日
一次修了 (実際)
2019年2月1日
研究の完了 (実際)
2019年2月1日
試験登録日
最初に提出
2016年11月21日
QC基準を満たした最初の提出物
2017年1月19日
最初の投稿 (見積もり)
2017年1月23日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月24日
QC基準を満たした最後の更新が送信されました
2019年4月23日
最終確認日
2018年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
外傷性脳損傷の臨床試験
-
Zagazig University積極的、募集していないGrade III Traumatic Splenic Injury in Hemodynamically Stable Patientsエジプト
採血の臨床試験
-
University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National Human Genome... と他の協力者完了新生児スクリーニング
-
Ischemia Care LLC完了虚血性脳卒中 | 心房細動 | 血栓性脳卒中 | 一過性脳虚血発作 | 心塞栓性脳卒中 | 脳底動脈の脳卒中 | 一過性脳血管イベントアメリカ
-
Applied Science & Performance Institute完了
-
Bedford Hospital NHS TrustAnglia Ruskin Universityわからない