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Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation

Study acronym: SOITBE
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Secondary endpoints: details revised at 2 of 6 entries
  2. Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Oct 31, 2025 to Oct 1, 2025
    • Interventions modified
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (6)
    • Collaborators revised (13)
  3. Changed Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University to Second Affiliated Hospital, Zhejiang University, School of Medicine
  4. Primary and study completion dates: Dec 31, 2021 to Oct 31, 2025v4 Show 6 more changesShow less
    • Primary endpoints: 3 to 1
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 360 to 380
    • Secondary endpoints: 3 to 6
    • Site details revised
    • Collaborators: 12 to 13
  5. Primary completion date: Dec 31, 2020 to Dec 31, 2021v3
  6. Secondary endpoints: details revised at 1 of 3 entries
    • Collaborators expanded, about 71 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03957707
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborators: Sir Run Run Shaw Hospital, Ningbo No. 1 Hospital, Ningbo Medical Center Lihuili Hospital, Second Affiliated Hospital of Wenzhou Medical University, Affiliated Wenling Hospital of Wenzhou Medical University, Zhuji People's Hospital of Zhejiang Province, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Jinhua Central Hospital, Huzhou Central Hospital, People's Hospital of Quzhou, The Second Affiliated Hospital of Jiaxing University, Xiaoshan Hospital, Lishui Country People's Hospital
Conditions
(from sponsor)		 Basal Ganglia Haematoma
Related terms Basal Ganglia Hemorrhage
Enrollment 380 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov