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

NCT01050049 | Completed

• 1 other identifier: 11959
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Study Arms (2)

Before guidelines implemented

After guidelines implemented

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to the Emergency Department with acute stroke

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 15, 2010
• Last Updated: January 15, 2010

Record last verified: 2008-10

Locations

US (1)