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Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window

NCT ID: NCT01770197

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-12-31

Brief Summary

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The time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. Little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese stroke patients. This exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in China.

Detailed Description

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Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up. The safety of intravenous recombinant tissue plasminogen activator was assessed by the rate of mortality, intracerebral hemorrhage and other common complications. Multivariate logistic regression models were used to evaluate factors associated with favorable clinical outcome.

Conditions

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Stroke

Keywords

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China Stroke Thrombolytic therapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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recombinant tissue plasminogen activator

Stroke patients with rt-PA treatment in the 3-4.5 hour time window were compared with those within 3h.

IV rt-PA

Intervention Type DRUG

IV rt-PA treatment

rt-PA

One group of was treated with standard recombinant tissue plasminogen activator therapy in 3h and the other group of stroke patients was treated within 3-4.5h.

IV rt-PA

Intervention Type DRUG

IV rt-PA treatment

Interventions

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IV rt-PA

IV rt-PA treatment

Intervention Type DRUG

Other Intervention Names

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rt-PA

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan General Hospital of Guangzhou Military Command

OTHER

Sponsor Role lead

Responsible Party

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zhipeng xu

Wuhan General Hospital of Guangzhou Military Command

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wuhan G H, High

Role: STUDY_CHAIR

Wuhan General Hospital of Guangzhou Command

Related Links

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http://ClinicalTrials.gov

Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window

Other Identifiers

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20090101

Identifier Type: -

Identifier Source: org_study_id