Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II (NCT04172376) | Clinical Trial Compass
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Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II
400 participantsStarted 2021-01-01
Plain-language summary
Spontaneous cerebral hemorrhage is one of the main causes of death and disability all over the world, accounting for 20%-30% of all cerebrovascular diseases. Minimally invasive surgery of cerebral hemorrhage, especially puncture aspiration, can improve early and long-term neurological recovery in patients with cerebral hemorrhage. Until now, no standardized practice for minimally invasive surgery of spontaneous cerebral hemorrhage has been established. Hematoma puncture and drainage based on CT scans without precise localization and personalized approach design, which may lead to poor efficacy and high risk of complications. The investigators' hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So the investigators conduct a prospective multicenter randomized controlled clinical trial across the country to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a volume of 15-30 mL calculated by ABC/2 formula and Glasgow Coma Scale score of at least 9.
✓. With dysfunctions such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15.
✓. Hematoma volume increase \<5 ml by ABC/2 formula shown by an additional CT scan after at least 6 hours of the diagnostic CT.
✓. Diagnostic CT scans should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded.
✓. Randomization within 72 hours after diagnostic CT.
✓. Surgery performed within 72 hours after onset.
✓. SBP \<180 mmHg recorded for 6 hours prior to randomization.
✓. Age between 18-70 years old.
Exclusion criteria
✕. Hematoma involves thalamus, midbrain and other structures.
What they're measuring
1
Change of ADL score
Timeframe: at 6 months of follow-up
Trial details
NCT IDNCT04172376
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
✕. Mass effect or hydrocephalus due to intraventricular hemorrhage.
✕. Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation (AVM) and moyamoya disease, hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.
✕. Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
✕. Patients with unstable hematoma or with progression to intracranial hypertension syndrome.
✕. Patients with any irreversible coagulopathy or known coagulation disorders; platelet count \< 100,000; INR \> 1.4.
✕. Patients requiring long-term use of anticoagulants.
✕. Patients taking dabigatran, apixaban, and/or rivaroxaban (or similar drugs of the same category) before symptoms arise.