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

Launched by RENJI HOSPITAL · Jan 12, 2020

Keywords

ClinConnect Summary

This clinical trial is looking into the treatment and recovery outcomes for patients with acute epidural hematoma, a type of brain injury that can occur after a traumatic event, such as a fall or car accident. The study is taking place in several hospitals across China and aims to understand how well current surgical treatments work and to find ways to improve them. The researchers want to gather real-world data to see how patients respond to surgery and what factors might influence their recovery.

To be eligible for this study, participants must have a clear history of a traumatic brain injury and be treated within 12 hours of their injury. They should have a specific type of brain injury called a unilateral acute epidural hematoma that requires surgical intervention. However, individuals with certain serious conditions or previous surgeries, as well as pregnant women, cannot participate. If you join the study, you can expect to receive standard care for your injury while also contributing to important research that could help improve treatment for future patients.

Gender

ALL

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.