Condition or disease | Intervention/treatment |
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Ischemic Stroke | Drug: Alteplase Drug: Urokinase |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China |
Estimated Study Start Date : | March 1, 2018 |
Estimated Primary Completion Date : | September 1, 2020 |
Estimated Study Completion Date : | September 1, 2020 |
Group/Cohort | Intervention/treatment |
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Alteplase group
According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion
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Drug: Alteplase
According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion.
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Urokinase group
1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End
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Drug: Urokinase
1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
China, Liaoning | |
General Hospital of Shenyang Military Region | |
Shenyang, Liaoning, China |
Principal Investigator: | Huisheng Chen, doctor | Neurology Chief |
Tracking Information | |||||||
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First Submitted Date | November 14, 2017 | ||||||
First Posted Date | June 25, 2019 | ||||||
Last Update Posted Date | June 25, 2019 | ||||||
Estimated Study Start Date | March 1, 2018 | ||||||
Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
mRS of 90 days after thrombolysis [ Time Frame: Month 3 ] Proportion of patients with mRS = 0-1 points 90 days after thrombolysis
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Original Primary Outcome Measures | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures |
Evaluation of Adverse events [ Time Frame: Year 1 ] Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
Economic evaluation [ Time Frame: Day 14 ] The cost-effectiveness of different thrombolytic drugs
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title | Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China | ||||||
Official Title | Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China | ||||||
Brief Summary | To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China | ||||||
Detailed Description | Compare the efficacy and safety of different thrombolytic drugs; Analysis of patients during hospital treatment of adverse events and complications; Analysis of factors that affect the effectiveness of treatment; Evaluate the pharmacological benefits of different thrombolytic drugs | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Retention: Samples With DNA Description:
blood
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Sampling Method | Non-Probability Sample | ||||||
Study Population | Thrombolytic patients with acute ischemic stroke within 3 hours of onset | ||||||
Condition | Ischemic Stroke | ||||||
Intervention |
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Study Groups/Cohorts |
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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 | Withdrawn | ||||||
Actual Enrollment |
0 | ||||||
Original Actual Enrollment | Same as current | ||||||
Estimated Study Completion Date | September 1, 2020 | ||||||
Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03997292 | ||||||
Other Study ID Numbers | K201707 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Hui-Sheng Chen, General Hospital of Shenyang Military Region | ||||||
Study Sponsor | General Hospital of Shenyang Military Region | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | General Hospital of Shenyang Military Region | ||||||
Verification Date | June 2019 |