The Treatment Effect of Endoscopic Evacuation Versus Suboccipital Craniotomy for Spontaneous Intr… (NCT04991233) | Clinical Trial Compass
UnknownNot Applicable
The Treatment Effect of Endoscopic Evacuation Versus Suboccipital Craniotomy for Spontaneous Intracerebellar Hemorrhage.
China190 participantsStarted 2021-03-01
Plain-language summary
The purpose of the present study is to compare the effectiveness and safety of two surgery evacuation methods (endoscopic surgery and suboccipital craniotomy) in the treatment of acute spontaneous cerebellar hemorrhage (SCH). A multi-center randomized control trial will be conducted. Patients with an initial GCS score of 5-14 will be screened and enrolled in the first 24 hours after SCH.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18-80 years old;
. Cerebellar hemorrhage was confirmed by computed tomography (CT) scans;
. The hematoma was \> 3 cm in diameter or the hematoma volume was \> 10ml or the hemorrhage is associated with brainstem compression or hydrocephalus;
. The randomization can be conducted within 24 hours;
. GCS score at randomization was 5-14;
. mRS was 0-1 before onset;
. The systolic pressure was controlled below 180 mmHg before randomization;
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.
. Informed consent was obtained from the patient and his legal representative.
Exclusion criteria
. Coexistent intracranial bleeding from other sites;
. Brain herniation before randomization;
. Bleeding caused by other reasons such as aneurysm, arteriovenous malformation, trauma, and tumor; hemorrhage secondary to large cerebral infarction, beta-amyloid degeneration disease, or coagulation dysfunction; coexistent aneurysm, arteriovenous malformation, brain trauma, brain tumors, large area cerebral infarction, beta-amyloid degeneration disease, or serious blood coagulation disorders;
. A history of cerebral hemorrhage within 1 year;
. A history of intracranial surgery or hemorrhagic disease (intracerebral hemorrhage, subarachnoid hemorrhage, subdural or epidural hemorrhage) within the last 30 days;
. Warfarin, dabigatran, rivaroxaban, and other anticoagulant drugs were given within one week before enrollment, and the INR was \> 1.4;
. Aspirin, clopidogrel, ticagrelor, and other antiplatelet drugs were given within one week before enrollment, and the inhibition rate of AA-dependent pathway \> 50%，inhibition rate of ADP-dependent pathway \> 30%;