Outcome of Patients With Mild Head Injury and Presence of an Acute Traumatic Abnormality on CT Scan of Head
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Neurosurgical intervention
研究概览
简要总结
Background: Patients with mild blunt traumatic brain injury (TBI) are frequently transferred to Level 1 trauma centers (L1TC) if they have any positive finding of any acute intracranial injury identified on a CT scan of the head. The hypothesis for the study is that patients with such injuries and minor changes on the Head CT scan can be safely managed at community hospitals (CH).
Methods: Patients with blunt, mild TBI (defined as a GCS 13-15 at presentation) presenting to CH, L1TC, and transferred from CH to L1TC between March, 2012 and February, 2014 were included. Minor changes on head CT were defined as: 1) epidural hematoma<2mm; 2) subarachnoid hemorrhage<2mm; 3) subdural hematoma<4mm; 4) intraparenchymal hemorrhage<5mm; 5) minor pneumocephalus; or 6) linear or minimally depressed skull fracture. TBI-specific interventions were defined as intracranial pressure monitor placement, administration of hyperosmolar therapy, or neurosurgical operation. Three groups of patients were compared: 1) those receiving treatment at CH, 2) those transferred from CH to L1TC, and 3) those presenting directly to L1TC.
The primary endpoint was the need for TBI-specific intervention and secondary outcome was death of any patient.
详细描述
Methods
The trauma registries at all participating centers were searched for patients who developed mild TBIs following blunt trauma and were directly admitted either to L1TC, or CH, or transferred from CH to L1TC. Patients with Glasgow Coma Scale (GCS) equal to or greater than 13 and a positive head CT scan for minor injuries were included in the study. Minor CT findings were defined as: 1) an epidural hematoma less than 2 mm thick, 2) a subarachnoid hemorrhage measuring less than 2 mm, 3) a subdural hematoma less than 4 mm thick, 4) an intraparenchymal hemorrhage measuring less than 5 mm, 5) minor pneumocephalus, or 6) linear or minimally depressed skull fracture. Patients with multiple findings were also included so long as the above criteria were met. Patients were also included patients if they were taking aspirin or if they were intoxicated with alcohol as long as their GCS could still be assessed to be between 13-15. Patients with more severe CT scan findings were excluded. Patients were also excluded if they were younger than 18 years of age, presented with open skull fractures, were intubated or hemodynamically unstable upon presentation, or had prior history of bleeding diathesis. Finally, patients with injuries in other areas of the body with an abbreviated injury score (AIS) > 2 were excluded.
After obtaining approval by the Institutional Review Board, data of interest was retrospectively collected from one LITC and four CH. This was done by using the trauma registries and reviewing individual medical charts. Collected data included baseline demographics (e.g. age and gender), variables related to the blunt trauma (e.g. mechanism of injury, injury severity score [ISS], and AIS scores), baseline comorbidities, vital signs and GCS on arrival to the emergency department, CT scan findings and whether a repeat CT scan of the head was performed, the administration of blood products, hospital and intensive care unit (ICU) length of stay, as well as in-hospital complication and mortality rates.
Three groups of patients were compared:
- those who were admitted and received definitive treatment at one of the four CH
- those who initially presented at CH but were subsequently transferred to L1TC and
- those who presented directly to the L1TC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blunt Trauma to Head
- •Patients with Glasgow Coma Scale (GCS) 13-15
- •Head CT scan showing the following minor changes
- •an epidural hematoma less than 2 mm thick
- •a subarachnoid hemorrhage measuring less than 2 mm
- •a subdural hematoma less than 4 mm thick
- •an intraparenchymal hemorrhage measuring less than 5 mm
- •minor pneumocephalus defined as 2-3 small bubbles of intracranial air
- •linear or minimally depressed skull fracture
- •Patients who had more than one of the above findings were also included
- •Patients on aspirin were included
- •Patients who were intoxicated with alcohol were included if their GCS could still be assessed as being between 13-15 -
排除标准
- •Patients with more severe CT scan findings than those noted above
- •Less than 18 years of age
- •Open skull fractures
- •Intubated patients
- •Hemodynamically unstable upon presentation
- •Prior history of bleeding diathesis
- •Patients with severe extracranial injuries - defined as Abbreviated Injury Scale (AIS) greater than or equal to 3 in any other body region -
结局指标
主要结局
Neurosurgical intervention
时间窗: 30 days after admission with minor Head Injury
1. Patients requiring Hyperosmolar therapy - either mannitol or hypertonic saline. 2. Neurosurgical operation 3. Insertion of an Intracranial pressure monitor
次要结局
- Death(30 days after admission with minor head injury)
研究者
Sanjay Gupta, M.D.
Instructor in Surgery
Massachusetts General Hospital