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Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03997292
Enrollment
0
Registered
2019-06-25
Start date
2018-03-01
Completion date
2020-09-01
Last updated
2019-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

alteplase; urokinase; intravenous thrombolysis

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

Interventions

DRUGAlteplase

According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion.

1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.

Sponsors

General Hospital of Shenyang Military Region
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 1\) age\> 18 years old; * 2\) meet the diagnostic criteria of China 2014 guidelines for the diagnosis and treatment of acute ischemic stroke; * 3\) no history of first sepsis or previous cerebral infarction sequelae (mRS ≤ 1); * 4\) within 3 hours of onset; * 5\) Have measurable neurological deficits; * 6\) Patients or legal guardians can understand and sign informed consent.

Exclusion criteria

* Absolute

Design outcomes

Primary

MeasureTime frameDescription
mRS of 90 days after thrombolysisMonth 3Proportion of patients with mRS = 0-1 points 90 days after thrombolysis

Secondary

MeasureTime frameDescription
Evaluation of Adverse eventsYear 1Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding

Other

MeasureTime frameDescription
Economic evaluationDay 14The cost-effectiveness of different thrombolytic drugs

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026