A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- GOSE (extended Glasgow Outcome Scale) scores
研究概览
简要总结
This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.
详细描述
The incidence of Acute Epidural Hematoma (AEDH) among traumatic brain injury (TBI) patients has been reported to be in the range of 2.7 to 4%. The mortality in patients in all age groups and GCS scores undergoing surgery for evacuation of EDH is approximately 10%.
Most people with EDH are generally expected to have a good clinical outcome with the prompt and correct treatment. However, AEDH still represents a potentially life-threatening condition when a local mass effect exists due to rapidly elevated intracranial pressure (ICP) resulted from the rapid build-up of blood. Brain hernia and cerebral infarction might occur and lead to a terrible clinical outcome. In addition, there is a set of patients who experience clinical deterioration after an initial hematoma-evacuation craniotomy because of secondary brain injuries, including massive cerebral infarction (MCI), additional decompressive craniectomy is recommended as soon as possible.
Although DC can reduce the morbidity and mortality in critically ill patients with a sTBI, the removal of the bone flap is not necessary for the majority of patients with AEDH, because of the relatively low incidence of MCI secondary to AEDH. Recommendations indicated an epidural hematoma greater than 30 ml should be surgically evacuated regardless of the patient's GCS score. Although craniotomy provides a complete evacuation to remove the clot of the hematoma, there are insufficient data to support a specific surgical treatment method. The choice of operative technique is influenced by the surgeon's expertise, training, and evaluation of a particular situation. Therefore, there is a clinical rationale for investigating the current status of surgical treatments and prognosis for AEDH, thereby providing a reliable reference for the optimization of therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clear medical history of traumatic brain injury;
- •within 12 hours after injury;
- •Supratentorial unilateral acute epidural hematoma on first head CT scan examination;
- •The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with surgical treatment;
- •With informed consent to surgery and trial participation.
排除标准
- •Previous intracranial surgery prior to trauma;
- •Patients with a score of 3 on the GCS, with bilateral fixed and dilated pupils, bleeding diathesis or defective coagulation, or an injury that was deemed to be unsurvivable;
- •CT demonstrates associated other intracranial hematomas e.g. subdural, intracerebral hemorrhage, or large size infarction, which are the main causes of operation;
- •Patients who had injury of the oculomotor nerve;
- •Severe pre-existing disability or severe co-morbidity which would lead to a poor outcome even if the patient is supposed to a good recovery from the TBI;
- •Pregnant female.
结局指标
主要结局
GOSE (extended Glasgow Outcome Scale) scores
时间窗: at 6 months post-injury
The primary outcome is indicated by the long-term functional outcomes, including overall mortality and the score on the Extended Glasgow Outcome Scale (GOS-E), "Extended Glasgow Outcome Scale" is the unabbreviated scale title. The minimum value of scale is score 1, and maximum value is scored 8, higher scores mean a better outcome and lower scores mean worse outcome. Specific scored as follows: 1. death; 2. persistent vegetative state; 3. lower severe disability; 4. upper severe disability; (stratum 3 and 4 were considered as severe disability, with permanent requirement for help with daily living); 5. lower moderate disability; 6. upper moderate disability; (stratum 5 and 6 were considered as mild disability, without a need for assistance in everyday life, that might, however, require special equipment for employment); 7. lower good recovery; 8. upper good recovery (stratum 7 and 8 were considered as good recovery).
次要结局
- length of stay in ICU and hospital(within 6 months post-injury)
- detailed economic evaluation(within 6 months post-injury)
- incidence of serious adverse events(within 6 months post-injury)
- quality of life (EQ-5D-5L)(at 6 months post-injury)
- MMSE (mini-mental state examination) scores(at 6 months post-injury)
- incidence of post-operative cerebral infarction(within 6 months post-injury)
- incidence of additional craniocerebral surgery(within 6 months post-injury)