Condition or disease | Intervention/treatment | Phase |
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Basal Ganglia Haematoma | Procedure: stereotactic surgery plus thrombolysis | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation: a Randomized Controlled Trial. |
Actual Study Start Date : | January 1, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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Experimental: stereotactic surgery with drugs treatment |
Procedure: stereotactic surgery plus thrombolysis
stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent
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Sham Comparator: drugs treatment alone |
Procedure: stereotactic surgery plus thrombolysis
stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Participating in other interventional medical research or clinical trials at the same time.
Patients enrolled in observational, natural history and/or epidemiological studies (without intervention) are eligible for this trial.
China, Zhejiang | |
the Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting |
Hangzhou, Zhejiang, China, 310009 | |
Contact: gao chen 8613805716226 d-gaochen@zju.edu.cn |
Tracking Information | |||||
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First Submitted Date ICMJE | May 19, 2019 | ||||
First Posted Date ICMJE | May 21, 2019 | ||||
Last Update Posted Date | October 22, 2020 | ||||
Actual Study Start Date ICMJE | January 1, 2019 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation | ||||
Official Title ICMJE | Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation: a Randomized Controlled Trial. | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Basal Ganglia Haematoma | ||||
Intervention ICMJE | Procedure: stereotactic surgery plus thrombolysis
stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
360 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03957707 | ||||
Other Study ID Numbers ICMJE | 2018-222 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
Study Sponsor ICMJE | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||
PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |