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

NAActive, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 23, 2020

Primary Completion Date

September 14, 2025

Study Completion Date

December 31, 2025

Conditions
Epidural HematomaBrain HerniationDecompressive CraniectomyCraniotomy
Interventions
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.

Trial Locations (1)

Unknown

Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai

All Listed Sponsors
collaborator

Shenzhen Second People's Hospital

OTHER

collaborator

Clinical Research Institute, Shanghai Jiao Tong University School of Medicine

UNKNOWN

lead

RenJi Hospital

OTHER

NCT04261673 - Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma | Biotech Hunter | Biotech Hunter