Active — Not RecruitingNot Applicable

Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma

China120 participantsStarted 2020-05-23

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

GOSE (extended Glasgow Outcome Scale) scores

Timeframe: 6 months post-injury

Trial details

NCT IDNCT04261673

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-14

View on ClinicalTrials.gov More Epidural Hematoma trials