Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Ep… (NCT04261673) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma
China120 participantsStarted 2020-05-23
Plain-language summary
Although craniotomy provides a more complete evacuation of the acute epidural hematoma, there are insufficient data to support specific surgical treatment method. We aim to perform a multi-center, parallel-group randomized clinical trial to compare the outcome and cost-effectiveness of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury patients with cerebral herniation undergoing evacuation of an acute epidural hematoma.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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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;
. Unilateral mydriasis or bilateral mydriasis before the operation;
. Acute supratentorial epidural hematoma and signs of brain stem compression on CT scan, representing the leading cause of operation, despite any other minor intracranial injuries associated (e.g., subarachnoid hemorrhage and contusion);
. The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with a craniotomy or decompressive craniectomy.
. With informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with a score of 3 on the GCS, with bilateral fixed and dilated pupils, bleeding diathesis or defective coagulation, or other injuries that were deemed to be unsurvivable;
. Patients who had injury of the oculomotor nerve;
. Patients are considered to be operated mainly by following pathological change on CT: subdural hematoma, intracerebral hemorrhage, large size infarction, et al., but not because of epidural hematoma;
. 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;