Observational study on surgical treatments for acute epidural hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, observational study investigates the current surgical treatments and outcomes for patients with acute epidural hematoma (AEDH) in China. It aims to analyze the effectiveness of various surgical approaches and optimize therapy for this life-threatening condition. The study focuses on patients who have experienced traumatic brain injury and require surgical intervention within 12 hours of injury. By collecting real-world data, the study seeks to improve understanding of treatment protocols and patient prognosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Clear medical history of traumatic brain injury;
2. within 12 hours after injury;
3. Supratentorial unilateral acute epidural hematoma on first head CT scan examination;
4. The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with surgical treatment;
5. With informed consent to surgery and trial participation.

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 an injury that was deemed to be unsurvivable;
3. CT demonstrates associated other intracranial hematomas e.g. subdural, intracerebral hemorrhage, or large size infarction, which are the main causes of operation;
4. Patients who had injury of the oculomotor nerve;
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.

Where it's running

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

Study contacts

• Study coordinator: Junfeng Feng, MD
• Email: fengjfmail@163.com
• Phone: +8613611860825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.