Which item is an exclusion criterion under DAWN trial criteria?

Which item is an exclusion criterion under DAWN trial criteria?

• A. Active hemorrhage within 30 days
• B. Severe head injury within 90 days with deficit
• C. Uncontrolled persistent BP >185 or D>110
• D. Baseline glucose outside 50-400

Answer: (B)

In this trial context, exclusion criteria are safety and accuracy filters to keep patients who might not benefit or could be harmed by the intervention out of the study. The item describing a severe head injury within the last 90 days with a persistent deficit is excluded because recent traumatic brain injury can create deficits that are hard to distinguish from the stroke itself and greatly increase the risk of bleeding after reperfusion therapy. This combination makes it unreliable to assess the true effect of the intervention and raises safety concerns, so such patients are not enrolled in DAWN. The other scenarios—recent active hemorrhage, uncontrolled high blood pressure, and abnormal baseline glucose—are important safety considerations in stroke care, but they don’t uniquely define DAWN’s exclusion in the same way as a recent severe head injury does.

In this trial context, exclusion criteria are safety and accuracy filters to keep patients who might not benefit or could be harmed by the intervention out of the study. The item describing a severe head injury within the last 90 days with a persistent deficit is excluded because recent traumatic brain injury can create deficits that are hard to distinguish from the stroke itself and greatly increase the risk of bleeding after reperfusion therapy. This combination makes it unreliable to assess the true effect of the intervention and raises safety concerns, so such patients are not enrolled in DAWN.

The other scenarios—recent active hemorrhage, uncontrolled high blood pressure, and abnormal baseline glucose—are important safety considerations in stroke care, but they don’t uniquely define DAWN’s exclusion in the same way as a recent severe head injury does.