![]() ![]() Methods The trial had two parts. Part 1 (in which 291 patients were enrolled) tested whether t-PA had clinical activity, as indicated by an improvement of 4 points over base-line values in the score of the National Institutes of Health stroke scale (NIHSS) or the resolution of the neurologic deficit within 24 hours of the onset of stroke. Part 2 (in which 333 patients were enrolled) used a global test statistic to assess clinical outcome at three months, according to scores on the Barthel index, modified Rankin scale, Glasgow outcome scale, and NIHSS. Results In part 1, there was no significant difference between the group given t-PA and that given placebo in the percentages of patients with neurologic improvement at 24 hours, although a benefit was observed for the t-PA group at three months for all four outcome measures. Tissue plasminogen activator (tPA) is known as a clot buster, an FDA-approved treatment for ischemic or thrombotic stroke. Get tissue plasminogen activator (tPA) information from the experts at Florida Hospital to see how this treatment is used for heart attack and stroke. Considered the gold standard,tissue plasminogen activator. When promptly administered, it can save lives and reduce the long-term effects of stroke. In part 2, the long-term clinical benefit of t-PA predicted by the results of part 1 was confirmed (global odds ratio for a favorable outcome, 1.7; 95 percent confidence interval, 1.2 to 2.6). As compared with patients given placebo, patients treated with t-PA were at least 30 percent more likely to have minimal or no disability at three months on the assessment scales. Symptomatic intracerebral hemorrhage within 36 hours after the onset of stroke occurred in 6.4 percent of patients given t-PA but only 0.6 percent of patients given placebo (P. Ischemic stroke affects over 400,000 people in the United States annually, and there is no direct treatment to reduce the extent of neurologic injury. Cerebral angiography conducted soon after the onset of stroke demonstrates arterial occlusions in 80 percent of acute infarctions. Thrombolytic canalization of occluded arteries may reduce the degree of injury to the brain if it is done before the process of infarction has been completed. Since intracerebral hemorrhage was a frequent major complication reported in early trials of thrombolytic therapy, the use of recombinant human tissue plasminogen activator (t-PA) for cerebral arterial thrombolysis requires a careful evaluation of both the risks and the potential benefits. The safety of intravenous t-PA for the treatment of acute cerebral ischemia was previously tested in two open-label, dose-escalation studies, which emphasized very early treatment — within 90 and 180 minutes of the onset of the stroke — to reduce the risk of hemorrhage and to maximize the potential for recovery. These studies suggested that doses of less than 0.95 mg of t-PA per kilogram of body weight were relatively safe and resulted in early neurologic improvement in a substantial proportion of patients.
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March 2018
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