NCT04229966 Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases
| NCT ID | NCT04229966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Epidural Hematoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2020-11-02 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2020-11-02 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Pregnant female.
Contact & Investigator
Jiyao Jiang, Professor
STUDY CHAIR
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Frequently Asked Questions
Who can join the NCT04229966 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Epidural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04229966 currently recruiting?
Yes, NCT04229966 is actively recruiting participants. Contact the research team at fengjfmail@163.com for enrollment information.
Where is the NCT04229966 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04229966 clinical trial?
NCT04229966 is sponsored by RenJi Hospital. The principal investigator is Jiyao Jiang, Professor at Renji Hospital, School of Medicine, Shanghai Jiao Tong University.. The trial plans to enroll 2,000 participants.