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
Inclusion Criteria5
- Clear medical history of traumatic brain injury;
- within 12 hours after injury;
- Supratentorial unilateral acute epidural hematoma on first head CT scan examination;
- The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with surgical treatment;
- With informed consent to surgery and trial participation.
Exclusion Criteria6
- Previous intracranial surgery prior to trauma;
- 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;
- CT demonstrates associated other intracranial hematomas e.g. subdural, intracerebral hemorrhage, or large size infarction, which are the main causes of operation;
- Patients who had injury of the oculomotor nerve;
- 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;
- Pregnant female.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04229966
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