RecruitingNCT04229966

Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases

A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma


Sponsor

RenJi Hospital

Enrollment

2,000 participants

Start Date

Nov 2, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is observing how acute epidural hematoma (AEDH) — a blood clot that forms between the skull and the brain after a head injury — is treated surgically across multiple centers. An AEDH is a medical emergency where blood rapidly accumulates and compresses the brain, and it typically requires urgent surgery to drain the clot and relieve the pressure. The study compares different surgical approaches and their outcomes. This is a large-scale observational registry study. It records how patients present, what surgical decisions are made, and what their outcomes are at discharge and follow-up. The goal is to identify best practices for this time-sensitive condition. You may be eligible if: - You are between 18 and 65 years old - You have a confirmed traumatic brain injury within the last 12 hours - You have a supratentorial (above the brainstem) unilateral acute epidural hematoma on CT scan - Your neurosurgeon has determined you need surgery to drain the clot You may NOT be eligible if: - You have had previous brain surgery before this injury - You have a GCS score of 3 with fixed dilated pupils, or your injury is considered unsurvivable - Your CT shows other significant brain bleeds (subdural or intracerebral hemorrhage) that are the main reason for surgery - You had an eye nerve (oculomotor) injury - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

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

Shanghai, Shanghai Municipality, China

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NCT04229966


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