鈍的副腎損傷 (BAD GUY) プロジェクト (BADGUY)
重大な外傷との関連で鈍的副腎損傷の疫学と負担を探る
Type: retrospective observational multicenter trial. Population of interest: adult patients suffering from thoraco-abdominal trauma undergoing both non-operative and operative management.
Hypothesis: Adrenal gland injury is a rare finding after blunt thoracoabdominal trauma. Short-term outcomes of blunt adrenal gland injury (BAGI) described in literature are contradictory. Reports on the outcomes related to this injury are variable and consider heterogeneous populations of trauma patients Aim: This study aims to explore the burden related to BAGI in an homogeneous population of patients sustaining blunt thoraco-abdominal trauma treated in different institution
調査の概要
状態
状態
詳細な説明
Adrenal gland injury is a rare finding after blunt thoracoabdominal trauma. The diagnosis can be accurately made with CT scan in stable patients, whilst in unstable patients, the detection can often be made during surgery, in the post-operative setting or postmortem. Short-term outcomes of blunt adrenal gland injury (BAGI) described in literature are contradictory. Studies reported BAGI as a high mortality risk injury. On the other hand, according to further reports, the presence of a BAGI is not considered a marker of severe injury or associated with an increased mortality rate.
Evidences the from a large multicenter cohort of selected trauma patients are lacking.
The study hypothesis is that BAGI is related to patients with higher trauma severity and worse overall outcome. By exploring the clinical burden related to BAGI the investigators aim to determine if this is related to the anatomical location of the injured organ or if in addition an underlying undisclosed pato-physiological mechanism is present. The investigatorspropose an international multicenter analysis on the epidemiology and the burden of BAGI in the context of major trauma, exploring differences between BAGI and non-BAGI patients.
Primary endpoint:
• Relationship between trauma severity (Injury Severity Score) of thoraco-abdominal trauma patients with BAGI versus torso trauma patients without BAGI
Secondary endpoint:
• Organ Injury Scale of the blunt adrenal trauma(OIS), overall survival, ICU length of stay, overall length of stay
Methods:
Patients will be enrolled according to the reported criteria. The following variables will be considered: - Demographic (age, sex, comorbidities) - Mechanism of trauma - Trauma bay and surgical management - Trauma severity (ISS, NISS, OIS, AIS) - Need for ventilation (Y/N, timing) - Data on vasoactive support - Post trauma clinical and laboratory parameters - Mortality - Length of stay (ICU, hospital) All information of patients will be extracted from our dedicated Trauma Registry and personal informations will be removed according to data anonymization, and collected in an electronic database.
Data will be reported in accordance with Strengthening the Reporting of Observational studies in Epidemiology guidelines (STROBE) for observational studies.
Statistical analysis A 1:1 propensity score matching analysis will be performed based on sex, setting of the trauma, trauma mechanism, age, ASA classification, intentionality of the trauma, Glasgow coma scale and Revised Trauma Score. Following the propensity score matching patients included with and without BAGI will be compared using χ2 test for categorical variables and t-student test or Mann-Whitney test according to sample distribution for continuous variables
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前:Stefano P Cioffi, MD
- 電話番号:+3386032519
- メール:stefanopiero.cioffi@ospedaleniguarda.it
研究連絡先のバックアップ
- 名前:Laura Benuzzi, MD
- メール:laura.benuzzi@unimi.it
研究場所
-
-
Lombardy
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Miano、Lombardy、イタリア、20162
- 募集
- ASST GOM Niguarda
-
コンタクト:
- Stefano Cioffi, MD
- 電話番号:+393386032519
- メール:stefanopiero.cioffi@ospedaleniguarda.it
-
-
参加基準
適格基準
適格基準
就学可能な年齢
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
patients presenting to ED diagnosed with acute appendicitis and eligible for laparoscopic appendectomy
説明
Inclusion criteria:
- Age > 16 years old
- All patients with blunt thoraco-abdominal trauma
Exclusion criteria:
- TBI with AIS > 3
- Isolated TBI and Spinal cord injury
- Patients died in emergency department
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
- 観測モデル:COHORT
- 時間の展望:RETROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
|---|
|
BAGI
patients suffering from thoraco-abdominal blunt trauma with and without blunt adrenal gland injury |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Injury Severity Score (ISS)
時間枠:120 days after trauma
|
The Injury Severity Score (ISS) is an established medical score to assess trauma severity.It correlates with mortality, morbidity and hospitalization time after trauma. It is used to define the term major trauma. A major trauma (or polytrauma) is defined as the Injury Severity Score being greater than 15.The AIS Committee of the Association for the Advancement of Automotive Medicine (AAAM) designed and improves upon the scale. Injury Severity Score Minimum: 0 Maximum: 75 The risk of mortality and post trauma complications raises with increasing values in Injury Severity Score. |
120 days after trauma
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence and number of thoraco-abdominal injuries
時間枠:120 days
|
The presence of a specific organ injury per each thoraco-abdominal organ will be registered, defining the presence of an injury as a dichotomous variable (0 absent, 1 present) |
120 days
|
|
Organ Injury Scale of the blunt adrenal trauma(OIS)
時間枠:120 days
|
The presence of a blunt adrenal gland injury will be registered and classified following the America Association for Surgery of Trauma Organ Injury Scale classification as follow: I Contusion II Laceration involving only cortex (<2 cm) III Laceration extending into medulla (> 2 cm) IV >50% parenchymal destruction V Total parenchymal destruction (including massive intraparenchymal hemorrhage) Avulsion from blood supply |
120 days
|
|
Overall survival
時間枠:120 days
|
The final outcome of the patient at 120 days will be registered as a dichotomous variable (0 survived, 1 dead) |
120 days
|
|
Overall length of stay
時間枠:120 days
|
The length of stay in the hospital will be recorded considering it as the time frame, in days, from patient's admission to the emergency department to death or to the discharge to home or a rehabilitation service |
120 days
|
|
Overall length of stay at ICU
時間枠:120 days
|
The length of stay in the Intensive Care Unit will be recorded considering it as the time frame, in days, from patient's admission in the ICU to death or to the discharge to a surgical or medical ward |
120 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
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