RecruitingNot Applicable

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

China2,000 participantsStarted 2020-11-02

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

GOSE (extended Glasgow Outcome Scale) scores

Timeframe: at 6 months post-injury

Trial details

NCT IDNCT04229966

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Junfeng Feng, MD

+8613611860825 fengjfmail@163.com

View on ClinicalTrials.gov More Epidural Hematoma trials