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Recruiting NCT04229966

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

Trial Parameters

Condition Epidural Hematoma
Sponsor RenJi Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,000
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2020-11-02
Completion 2027-12-31

Brief 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 Criteria

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. Pregnan

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