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

Status: Active_not_recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai
Time Frame
Start Date: 2020-05-23
Completion Date: 2025-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Decompressive Craniectomy
After the evacuation of epidural hematoma, the bone flap should not be replaced at the end of the operation.
Experimental: Craniotomy
After the evacuation of epidural hematoma, the bone flap must be replaced and fixed with an appropriate fixation system.
Sponsors
Collaborators: Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shenzhen Second People's Hospital
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov