NCT04261673

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

A Randomised Controlled Trial to Evaluate Decompressive Craniectomy for Patients With Cerebral Herniation Undergoing Evacuation of Acute Epidural Hematoma

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Epidural Hematoma
• Brain Herniation
• Decompressive Craniectomy
• Craniotomy

Interventions

Type	Name	Description
PROCEDURE	Decompressive Craniectomy	A large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. The bone flap should not be replaced at the end of the operation. DC has an advantage in controlling brain swelling, but patient is necessary to have another operation of cranioplasty to reconstruct the skull in the future.
PROCEDURE	Craniotomy	A large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. However, the bone flap must be replaced and fixed with fixation system (plates and screws). The patient will not need an additional operation to rebuild the skull in the future. But undisciplinable brain swelling and increased intracranial pressure may happen in some patients, and additional decompressive craniectomy is recommended in these cases.

Timeline

• Start date: 2020-05-23
• Primary completion: 2025-09-14
• Completion: 2025-12-31
• First posted: 2020-02-10
• Last updated: 2025-10-01

Locations

1 site across 1 country: China