The Treatment Effect of Endoscopic Evacuation Versus Suboccipital Craniotomy for Spontaneous Intr… (NCT04991233) | Clinical Trial Compass
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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 range18 Years – 80 Years
SexALL
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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;
✓. 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%;