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

This study has been completed.
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT01050049
First received: January 14, 2010
Last updated: NA
Last verified: October 2008
History: No changes posted

January 14, 2010
January 14, 2010
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No Changes Posted
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The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department
The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

Patients presenting to the Emergency Department with acute stroke

Stroke
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  • Before guidelines implemented
  • After guidelines implemented
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
19 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01050049
11959
No
Nina T. Gentile, MD, Temple University
Temple University
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Temple University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP