The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department

NCT ID: NCT01050049

Last Updated: 2010-01-15

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

COMPLETED

Study Classification

OBSERVATIONAL

Brief Summary

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The objective of this study is to determine if the implementation of guidelines utilizing immediate CT Perfusion and CT Angiography in addition to non-contrast CT alters (reduces or increases) the time to decision-making for or against rt-PA in acute ischemic stroke, and by extension, time to therapy in treated patients and time to transfer from the department for all patients. A secondary objective is to determine if using CTP/CTA-inclusive hyperacute stroke guidelines improves safety by decreasing symptomatic intracerebral hemorrhage and mortality in patients who receive rt-PA.

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Before guidelines implemented

No interventions assigned to this group

After guidelines implemented

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients presenting to the emergency Signs and symptoms of acute ischemic stroke: impairment of language, motor function, cognition and/or gaze, vision or neglect.
* Patients with an NIH Stroke Scale score \> 4

Exclusion Criteria

* Age less than 19
* Patient symptomatic for greater than five hours. Intravenous thrombolytic therapy must be instituted within three hours of symptom onset in order to minimize the risk of Intracerebral or symptomatic hemorrhage; other interventions such as intra-arterial thrombolytic therapy and clot retrieval allow for a six-hour window. One hour is an achievable time for arrival to institution of therapy, therefore a five-hour limit on enrollment allows the greatest number of patients the possibility of therapy.
* Inability to verify a clear onset of symptoms. As noted, time elapsed since the patient's last known baseline state is correlated to Intracerebral and symptomatic hemorrhage, and therapy is approved only for patients with a clear time of onset.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role lead

Responsible Party

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Temple University

Locations

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Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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11959

Identifier Type: -

Identifier Source: org_study_id

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