Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury (GNOS)
Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury - a Multi-centre, International, Prospective Cohort Study (the Global Neurotrauma Outcomes Study)
Primary aim:
The primary aim of the study is to compare survival to discharge (or survival to 14 days post-operatively, whichever comes first) following emergency surgery for traumatic brain injury (TBI) across Human Development Index settings.
Primary outcome measure:
The primary outcome measure will be survival to discharge (or survival to 14 days post-operatively, whichever comes first)
Primary comparison:
Between country groups defined by human development index.
Centre eligibility:
Any hospital or clinic worldwide performing emergency surgery for traumatic brain injury is eligible to participate.
Patient eligibility:
All adult and paediatric patients admitted to the participating institution with a traumatic brain injury for which they receive emergency surgery during the selected 30-day inclusion period are eligible for inclusion in the study.
Team:
Individual hospital teams with up to four people, collecting data for 30 days.
Time period:
Local study teams may select any 30-day period from the 1st of November 2018 and the 31st of December 2019 to start their study. Patients operated on who meet the inclusion criteria between 00:01 on day 0 and 23:59 on day 30 of the selected study period will be included.
Validation:
We will employ a method of data validation in every centre that will give us a quantitative estimate of case ascertainment that is feasible even in low-resource centres.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Cambridgeshire
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Cambridge、Cambridgeshire、イギリス、CB2 0QQ
- 募集
- University of Cambridge
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コンタクト：
- David Clark
- 電話番号：+441223336946
- メール：gnos@globalneurotrauma.com
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コンタクト：
- Peter Hutchinson
- 電話番号：+441223336946
- メール：gnos@globalneurotrauma.com
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Centre Inclusion Criteria:
Any hospital or clinic worldwide performing emergency surgery for traumatic brain injury is eligible to participate. In the majority of institutions, emergency surgery for TBI is provided by neurosurgeons - however, centres in which emergency surgery for TBI is provided general surgeons, trauma surgeons, general medical doctors or even non-physician clinicians are also eligible to participate.
Inclusion Criteria:
- All adult and paediatric patients admitted to the participating institution with a traumatic brain injury for which they receive emergency surgery during the selected 30-day inclusion period are eligible for inclusion in the study.
Exclusion Criteria:
- Patients who only have an external ventricular drain or intraparenchymal wire (or other monitoring device) inserted for the diagnosis and/or management of intracranial hypertension.
- Patients who undergo procedures for chronic subdural haematoma(s), including burr holes or mini-craniotomies.
- Elective (planned admission) or semi-elective (where patient initially admitted as an emergency, then discharged from hospital, and re-admitted at later time for surgery) procedures.
- Patients who have previously had emergency cranial surgery for traumatic brain injury rendering them eligible for inclusion in this study (regardless of whether they were included)
研究計画
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 |
|---|---|
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Procedure: Emergency surgery for traumatic brain injury
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一次比較: 人間開発指数によって定義された国グループ間の比較。
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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 |
|---|---|
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In-hospital mortality (or 14 day mortality, whichever comes first)
時間枠：Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perioperative complications: Return to operating theatre
時間枠：Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Including reason for return.
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Perioperative complications: Surgical site infection (SSI)
時間枠：Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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SSI is stratified into superficial and deep/organ space infection.
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Length of stay in hospital (days)
時間枠：Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Length of stay in intensive care (days)
時間枠：Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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For patients admitted to intensive care.
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Glasgow Coma Score at discharge/end of follow up period
時間枠：At hospital discharge 14 days postoperatively, whichever comes first
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3-15, 3 signifies no eye opening, verbal response or motor response to painful stimulus, 15 signifies no impairment to consciousness.
For patients surviving to discharge and/or 14 days postoperatively.
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At hospital discharge 14 days postoperatively, whichever comes first
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Location that the patient was discharged to
時間枠：Within 14 days post-operatively, only applies to patients who are discharged within this time period.
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For patients surviving to discharge and discharged within 14 days post-operatively.
Categorical variable for which the options are 'transfer to another hospital', 'transfer to rehabilitation unit', 'usual place of residence' and 'absconded'.
A surrogate measure of short term functional outcome.
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Within 14 days post-operatively, only applies to patients who are discharged within this time period.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：David Clark、University of Cambridge
- 主任研究者：Peter Hutchinson、University of Cambridge
- 主任研究者：Alexis Joannides、University of Cambridge
- 主任研究者：Angelos Kolias、University of Cambridge
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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