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Brain surgery showdown: which procedure saves more lives after severe head trauma?

NCT ID NCT04261673

Disease control Sponsor: RenJi Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of brain surgery for people with a severe head injury that causes a blood clot (epidural hematoma) and brain herniation. One surgery removes the clot and a piece of skull to relieve pressure; the other removes the clot without removing skull bone. The goal is to see which approach leads to better long-term recovery and fewer complications. About 120 participants are being followed after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2020

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Clear medical history of traumatic brain injury; 2. Within 12 hours after injury; 3. Unilateral mydriasis or bilateral mydriasis before the operation; 4. 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); 5. The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with a craniotomy or decompressive craniectomy. 6. With informed consent. Exclusion Criteria: 1. Previous intracranial surgery prior to trauma; 2. 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; 3. Patients who had injury of the oculomotor nerve; 4. 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; 5. 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; 6. Pregnant female.

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Conditions

The condition(s) this trial relates to.

Hematoma, Epidural, Spinal traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain herniation Craniotomy Decompressive craniectomy Epidural hematoma

Contacts and locations

Locations

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

    Shanghai, Shanghai Municipality, China

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