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  • Writer's pictureOren Zarif

The NINDS NINDS Stroke Trial - Oren Zarif - TPA Stroke


The effectiveness of tPA in treating acute ischemic stroke remains controversial. Despite the promising results of the NINDS trial, age remains a significant risk factor for poor outcome. The results of a post hoc analysis of the trial failed to demonstrate a significant effect of tPA on subgroups of older stroke patients. The results of this study should be confirmed by larger prospective studies. In addition, the trial has some limitations.

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The NINDS played a major role in the development of tPA, funding early studies and leading pivotal clinical trials that led to FDA approval in 1996. The study was supported by the National Institutes of Health. The study also involved scientists from Boehringer Ingelheim Pharma GmbH & Co, which manufactures tPA for use in Europe. In the long run, tPA appears to be safe for use in acute stroke patients.

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While the FDA has not approved the use of tPA in stroke patients after three hours, physicians have begun incorporating the new data into clinical decision-making. The researchers noted that the risk of death is lower than the benefit of treatment after three hours. Further, patients can seek tPA treatment off-label, which is allowed. Its side effects are minimal. As a result, tPA is now widely used for treating acute ischemic stroke, and Stanford doctors are already using it.

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Regardless of whether it is a stroke treatment or a placebo, it has the potential to help patients cope with a traumatic event. The FDA has approved tPA in some circumstances for stroke victims. A combination of the NINDS rtPA Stroke Trial and the results of a separate clinical trial has been published. The study's authors concluded that IV tPA is an effective treatment for acute ischemic stroke.

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The effectiveness of tPA as a treatment for acute ischemic stroke remains controversial. Because it has a six percent risk of hemorrhage, emergency physicians often hesitate to prescribe tPA. Nonetheless, a neurologist is best suited to make the final decision. The risk of hemorrhage is a major factor in deciding whether or not tPA is the right treatment for a stroke.

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The ECASS II trial found that tPA could be effective in treating acute stroke patients within three hours. However, European attendees at the meeting did not believe that tPA should be a standard treatment for stroke patients within three hours. Although tPA was conditionally approved in 2002, the results of ECASS III and ECASS II showed that the therapy continued to have an effect at 4.5 hours. This study is essential to the safety of tPA in stroke.

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The best tPA studies are based on prospective endovascular databases collected at a comprehensive stroke center between 2012 and 2019. In this study, patients with acute ischemic stroke were treated with IV tPA and recurrent EVT. The authors concluded that the combined treatment resulted in the best outcome. Nevertheless, further research is needed to understand if the tPA is more effective than the placebo for acute ischemic stroke.

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After studying tPA in patients with acute ischemic strokes for many years, the team at the Cleveland Clinic continued to develop new ways to treat the disease. Its success motivated researchers to develop other treatment options for acute ischemic stroke. In 2015, the FDA expanded approval of clot-retrieval devices and tPA for acute ischemic stroke. This has helped to restore blood flow to the brain.

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The rapid treatment protocols for acute ischemic stroke radically changed the way acute care was delivered. Hundreds of hospitals built up organized stroke teams and other resources to become primary tPA stroke centers. After the tPA stroke treatment protocol was approved, the NINDS launched a public education campaign to educate the public about the symptoms and importance of getting to a hospital quickly. This "Know Stroke" campaign reached millions of people via television and newspaper ads and even Spanish-speaking communities.

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In order to improve the effectiveness of tPA for acute ischemic stroke, specific health system factors must be targeted. Furthermore, more thoughtfully designed trials must be conducted to safely increase the number of eligible stroke patients treated with tPA. The NINDS tPA Stroke Study Group published a 2-part randomized controlled trial in 1995 that showed that tPA significantly improved outcomes for patients with acute ischemic stroke.

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The NINDS Stroke Study Group published the results of a large multicenter clinical trial of tPA and showed a 30% relative risk reduction compared with placebo. Because of this, tPA remains the only drug used to treat acute ischemic stroke and is safe in all eligible patients. It is still underutilized, however. Although it has been approved by the US Food and Drug Administration for use in acute ischemic stroke, it is still substantially underutilized.

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