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Medscape Reference

Thrombolysis May Benefit Some Patients Who Wake With Stroke

Susan Jeffrey

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March 5, 2009 — Results of a retrospective case series suggest that certain patients who wake with stroke symptoms may still benefit from intervention using intravenous (IV) or intra-arterial (IA) thrombolysis.

Researchers at the University of Texas–Houston report off-label use of thrombolysis in 46 patients with acute ischemic stroke appeared to be safe, with a rate of symptomatic intracerebral hemorrhage of 4.3%, and was associated with higher rates of excellent and favorable outcome, although mortality was also significantly higher than those who were not treated.

A second comparison of treated wake-up patients with those treated within the 3-hour time window after symptom onset showed no differences in safety and clinical outcomes.

"It's the first evidence that treating these patients who routinely do not get treated is potentially safe, and there's some implication that maybe they should not be excluded solely based on waking up with their symptoms," first author Andrew D. Baretto, MD, from University of Texas–Houston Health Science Center, told Medscape Neurology & Neurosurgery.

The findings are published in the March issue of Stroke. Senior author on the paper is Sean I. Savitz, MD, also from the University of Texas–Houston.

Contraindication

In general, patients who wake with stroke symptoms are not considered candidates for thrombolytic therapy, because the time of stroke onset cannot be established reliably. Tissue plasminogen activator (tPA) is approved by the Food and Drug Administration (FDA) for use in patients who present within 3 hours of a known symptom onset.

However, it is estimated that between 16% and 28% of patients who have a stroke each year wake up with their symptoms, Dr. Barreto said. "There are many patients for whom that is the only exclusion," he said. "You know everything else about these patients, all the labs are favorable, and then you find out he woke up with his symptoms," he said.

In some of these cases, when the computed tomography (CT) scan still shows radiologic features of a relatively recent ischemic event, their group has offered off-label, compassionate treatment with tPA, he said. In this study, they reviewed demographics, safety, and outcomes in these cases and compared them with wake-up stroke cases who did not receive thrombolysis, as well as outcomes in patients who met the 3-hour FDA-approved window for treatment.

Retrospective review of their database turned up 46 cases where thrombolysis was used in wake-up stroke patients; 28 (61%) of these received IV tPA, 14 (30%) were given only IA thrombolysis, and 4 (9%) received IV and IA tPA.

These were compared with 34 wake-up stroke patients who did not receive thrombolysis and 174 patients with an identifiable stroke onset who received thrombolysis within 3 hours of the start of symptoms.

After controlling for baseline National Institute of Health Stroke Scale (NIHSS) scores, they found that wake-up stroke patients who were treated had significantly higher rates of excellent and favorable outcomes on the modified Rankin Scale (mRS) but also had significantly higher mortality. There were 2 symptomatic intracranial hemorrhages in the treated group compared with none in untreated patients, but this difference did not reach statistical significance. Both of these had received IV tPA alone.

Posted

Our stroke protocol just got changed from 3hrs to 4.5hrs.

I dunno where the study is they based the change on...

Posted
Our stroke protocol just got changed from 3hrs to 4.5hrs.

I dunno where the study is they based the change on...

I think it's more about not making paramedics be the judge. If it's close we just narrow it down, and then let the stroke center make the final call. We actually took out or time and age criteria. if they are positive for Cincinnati stroke scale you can alert them. I don't call stroke alert if I know the symptoms began some time ago though. I think once we get some neuro-protective agents the criteria may change as well. Hypothermia is showing to have it's uses for CVA as well.

Posted

I learned at a CME put on by the head of our Stroke Center that if the hospital does that new "corkscrew" catheterization technique (too tired to remember the name, sue me), the window is as long as 8 hours.

Just something to keep in mind.

Posted

That is what defines a "comprehensive" stroke center. They use the corkscrew-like device, or they can disolve the clot with surgery (not tPa although that is an otion), or they can use this thing that goes past the clot and fills up like a bubble and pull it out that way. You are correct, comprehensive stroke centers allow 8 hours after onset. They aren't that abundent yet, we just got the surgeon and the device in my county but they are both at a facility not deemed a stroke center, go figure. The patient has to be transferred there by receiving facility.

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