We have previously discussed three trials from the early ‘90s. This list continues the theme by focusing on other studies conducted around that time.
This trial evaluated the administration of tPA across several time windows from 0-6 hours. The primary result compared proportions of patients with a 4-point or greater improvement at 30 days and at the moment of presentation.
Researchers noted a 15% absolute difference favoring the placebo arm. There were also statistically significant absolute increases in mortality and symptomatic ICH among tPA recipients.
This was an investigation of treatment in patients between 3-5 hours after the onset of symptoms. The main outcome was good neurological findings at 90 days. The researchers did not find a difference between groups. An ordinal analysis did not highlight a specific benefit either.
There was a 5.4% absolute increase in symptomatic intracranial hemorrhage in the tPA arm. Those who received tPA also saw higher mortality.
They put a stop to the trial because of futility. There were critics who said that had it continued, it would have eventually been stopped because of concerns of harm. Despite its negative outcomes, this trial was significant as the first negative tPA study.