Observational study on surgical treatments for acute epidural hematoma
A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma
This study looks at different surgical treatments for people in China with acute epidural hematoma after a brain injury to see which methods work best.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04229966 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with a clear history of traumatic brain injury and supratentorial unilateral acute epidural hematoma who require surgical evacuation.
Not a fit: Patients with severe pre-existing disabilities, bilateral fixed and dilated pupils, or other significant intracranial injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical strategies and better outcomes for patients with acute epidural hematoma.
How similar studies have performed: While there is limited data on specific surgical methods for AEDH, similar observational studies have shown promise in optimizing treatment protocols for traumatic brain injuries.
Eligibility criteria
Show full inclusion / exclusion 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. Pregnant female.
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.