"Flushing" Blood from Brain with Drug Reduced Death Risk in Hemorrhagic Stroke Patients
A drug to treat heart attacks and strokes was shown to decrease death rates by 10% in hemorrhagic stroke patients, according to newly shared trial results. The clot-busting drug, tPA (or tissue plasminogen activator), demonstrated significantly greater efficacy than saline in flushing unwanted blood from the brain.
The results come from Phase III of the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage III (CLEAR III) trial, which has run for five and a half years. One milligram of saline or tPA was administered via brain catherer to a randomized group of 500 patients aged between 18 to 80 with hemorrhagic stroke.
The 249 patients who received the saline had a death rate of 29% compared to 19% who received tPA. In addition, a significantly lower number patients receiving tPA had experienced adverse events; 49% compared to 62% in the saline control group. Such events included bacterial infections, bleeding and pneumonia.
“Hemorrhage in the brain used to be an essentially untreatable condition, but we now have hope with a therapy that may be effective at saving lives,” said co-author Issam Awad, MD, Professor of Surgery at the University of Chicago Medicine. One downside of the study findings was the physical and cognitive disability score. The number of patients who went home and lived independently from the tPA group was not significantly different than the number in the saline group (48% vs. 45%, respectively). The researchers had estimated a 13% better disability score with the drug.
The team members are planning a future trial, where tPA administration will have a greater degree of consistency, after they found room for improvement during a protocol evaluation.
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