A Randomised Controlled Trial to Evaluate Decompressive Craniectomy for Patients With Cerebral Herniation Undergoing Evacuation of Acute Epidural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- GOSE (extended Glasgow Outcome Scale) scores
研究概览
简要总结
Although craniotomy provides a more complete evacuation of the acute epidural hematoma, there are insufficient data to support specific surgical treatment method. We aim to perform a multi-center, parallel-group randomized clinical trial to compare the outcome and cost-effectiveness of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury patients with cerebral herniation undergoing evacuation of an acute epidural hematoma.
详细描述
The incidence of epidural hematoma (EDH) among traumatic brain injury (TBI) patients has been reported to be in the range of 2.7 to 4%. Among patients in coma, up to 9% harbored an EDH requiring craniotomy. The mortality in patients in all age groups and GCS scores undergoing surgery for evacuation of EDH is approximately 10%. The decision to operate on an acute EDH (AEDH) is usually based on the patient's GCS score, age, pupillary abnormalities, comorbidities, CT findings, associated intracranial lesions, in delayed decisions, the time between neurological deterioration and surgery, and intracranial pressure. An AEDH greater than 30 ml should be surgically evacuated regardless of the patient's Glasgow Coma Scale (GCS) score. There are insufficient data to support one surgical treatment method. However, craniotomy provides a more complete evacuation of the hematoma for patients with an AEDH that require an operation to remove the clot. But whether decompressive craniectomy (DC) should be employed still has considerable controversy. The choice of operative technique is influenced by the surgeon's expertise, training, and evaluation of a particular situation. The difference between these two procedures is that a bone flap is left out before closing the skin in DC. Both approaches are widely used among neurological surgeons (although the indications may differ), therefore there is sufficient experience in the centers to set up a randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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;
- •Unilateral mydriasis or bilateral mydriasis before the operation;
- •Acute supratentorial epidural hematoma and signs of brain stem compression on CT scan, representing the leading cause of operation, despite any other minor intracranial injuries associated (e.g., subarachnoid hemorrhage and contusion);
- •The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with a craniotomy or decompressive craniectomy.
- •With informed consent.
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 other injuries that were deemed to be unsurvivable;
- •Patients who had injury of the oculomotor nerve;
- •Patients are considered to be operated mainly by following pathological change on CT: subdural hematoma, intracerebral hemorrhage, large size infarction, et al., but not because of epidural hematoma;
- •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.
研究组 & 干预措施
Decompressive Craniectomy
After the evacuation of epidural hematoma, the bone flap should not be replaced at the end of the operation.
干预措施: Decompressive Craniectomy (Procedure)
Craniotomy
After the evacuation of epidural hematoma, the bone flap must be replaced and fixed with an appropriate fixation system.
干预措施: Craniotomy (Procedure)
结局指标
主要结局
GOSE (extended Glasgow Outcome Scale) scores
时间窗: 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, minimum value is 1 and maximum value is 8, which was scored as follows and higher scores mean a better outcome: 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
- incidence of post-operative cerebral infarction(within 6 months post-injury)
- incidence of additional craniocerebral surgery(within 6 months post-injury)
- length of stay in 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 1,3 and 6 months post-injury)
- MMSE (mini-mental state examination) scores(at 1,3 and 6 months post-injury)