Acute Subdural Hematoma with Herniation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years at randomization; 2.Clinical manifestations meeting the rapid diagnostic criteria for cerebral herniation: progressive deterioration of consciousness and pupillary dilation (GCS =4 mm, absent light reflex); 3.Cranial CT showing acute subdural hematoma with significant mass effect, with or without other intracranial injuries (e.g., epidural hematoma, cerebral contusion, or intracerebral hematoma), and judged by a neurosurgeon to require immediate evacuation of subdural hematoma and decompressive craniectomy; no time limit for the occurrence of trauma or subdural hematoma;
Exclusion criteria
Exclusion criteria: 1.Pupillary dilation caused by non-subdural hematoma reasons; 2.Previous craniocerebral surgery; 3.Concurrent brainstem or spinal cord injury affecting prognosis evaluation; 4.Inability to complete puncture and drainage due to various reasons, such as severe skull fracture; 5.Severe pre-existing physical or mental disabilities or comorbidities that would lead to poor outcomes even if the patient fully recovers from traumatic brain injury; 6.Meeting contraindications for neurosurgery (e.g., uncorrectable severe coagulopathy, severe vital sign instability due to systemic causes); 7.CT and clinical manifestations assessed by a senior neurosurgeon as having no chance of survival (e.g., hemispheric infarction after carotid artery occlusion, or bilateral fixed and dilated pupils with no spontaneous breathing for >1 hour); 8.Recent possibility of pregnancy or confirmed pregnancy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glasgow Outcome Scale Extended; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse events and surgical complications;Rate of repeat craniocerebral surgery;Mortality rate;EQ-5D score;Pupillary changes after craniotomy;Readmission to neurosurgery ward;Time from randomization/injury to completion of craniotomy;Pupillary changes after puncture drainage;Time from randomization/injury to skin incision for craniotomy;Hydrocephalus requiring shunt surgery;EQ-5D score;GCS score;Volume of hematoma drained via puncture;ICU length of stay;Intensity of treatment in ICU;Intracranial pressure;Glasgow Outcome Scale Extended;Instrumental Activities of Daily Living; | — |
Countries
China
Contacts
Qilu Hospital of Shandong University