Phase-3 clinical trial results show that using clot-busting drug alteplase may be the first effective treatment for decreasing mortality due to intraventricular hemorrhage (IVH), a severe form of stroke. Presented at the International Stroke Conference on Thursday, the results also point to the treatment's efficacy in reducing disability after strokes in a patient subset.
Issam Awad and colleagues carried out the CLEAR III clinical trial after a phase-2 trial was able to confirm safety and efficacy in administering the drug, also known as tPA, to IVH patients. The phase-3 clinical trial ran from 2009 to 2015, involving 500 patients. Aside from half of them were given alteplase while the others were assigned saline, all participants were provided standard critical care.
The researchers discovered that swiftly applying alteplase into brain ventricles, alongside a drainage catheter, led to a 10-percent reduction in overall deaths. At the same time, using the drug doubled the chances of good functional recovery in those with high volume bleeding who had most of their blood clots removed.
"For many patients, this approach can significantly reduce disability after a stroke, and can be the difference between going home instead of going to a nursing home," said Awad.
The researchers further analyzed their findings and found that the most crucial factor in improving recovery after a stroke was in the removed blood's volume. As more blood was cleared, chances of reduced disability grew.
Positive results from the CLEAR III trial led to the creation of a sister clinical trial called MISTIE. Co-led by Awad, it is designed to assess alteplase's effectivity in hemorrhagic stroke patients who experience bleeding in the brain but where blood does not pool in the ventricles.
Hemorrhagic strokes occur when blood vessels in the brain rupture. Blood leaks and pools, resulting in increased pressure in the brain which severely damages tissues. Blood quickly clots and is difficult to remove, even with open brain surgery. Only about 15 percent of strokes are of the hemorrhagic type, but they are responsible for some 40 percent of all deaths related to strokes.
Nearly half of bleeding strokes manifest some level of intraventricular bleeding, a complication where blood pools within the brain's ventricles. Unfortunately, IVH is particularly catastrophic, with a mortality rate estimated at 60 to 80 percent. Out of those who do survive, up to 90 percent have to live with severe disabilities.