Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation (NCT03957707) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation
China380 participantsStarted 2019-01-01
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. Our hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So we conduct a prospective multicenter randomized controlled clinical trial to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small to moderate 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 \< 30 mL calculated by ABC/2 formula and Glasgow Coma Scale score ≥ 9.
✓. With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15 points.
✓. Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase \< 5 ml by ABC/2 formula)
✓. Diagnostic CT scan 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 should be performed within 72 hours after onset.
✓. SBP \<180 mmHg maintained for 6 hours prior to randomization.
✓. Age between 18-70 years old.
Exclusion criteria
✕. Hematoma involves other structures such as the thalamus and midbrain.
What they're measuring
1
Favorable Functional Outcome as Defined by the modified Rankin Scale (mRS) Score
Timeframe: 6 months
Trial details
NCT IDNCT03957707
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 as well as 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 unsteady 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.