Each year in the United States, 700,000 have a stroke, and 15 percent of those are intracerebral hemorrhages (ICH). The average age for patients is those in their 60s, and the biggest risk factor for it is hypertension.

When hypertension goes untreated, according to Christiana Hall, MD, a neurologist at the Medical College of Georgia in Augusta, "small penetrating vessels in the deep parts of the brain that are bombarded with high pressures undergo changes. They thicken, develop tiny little out-pouches that destabilize and make them weaker. Then, one day, one of these tiny penetrators just gives out and bleeds into the brain tissue." The bleeding tears brain tissue and disrupts huge bundles of fibers that carry information.

Patients can experience one-sided paralysis, coma, locked-in syndrome where they are fully conscious but paralyzed from the eyes down, or death.

ICH is the least treatable form of stroke, with no proven effective treatment. Blood-clotting drugs have been tried but not shown to work. The outcome of these strokes depends on the size and location of the hemorrhage.

There are five common locations -- most in deep brain structures. When the hemorrhage is in a deep brain structure and is large, patients have a one-month mortality of 90 percent. Hall said for patients alive at six months, "Really only about 20 percent are independent and can resume their former lives to any degree." Up to 38 percent of hemorrhages increase in size within the first six hours. The idea for an effective agent is to stop the growth early on.

"If we had an agent which could stop hemorrhage growth in its tracks, then this would certainly be the first step towards finding something that will make a difference for these patients. Anything that would bring us closer to keeping the patient the way they were when they came in would be fantastic," Hall said.

Now, there is a growth factor under study at about 100 sites worldwide. It is called NovoSeven, or activated factor VIIa, and is part of the body's natural clotting process. It is approved for treating some forms of hemophilia. Activated factor VIIa needs to be given as soon as possible after the onset of a stroke -- much like tPA, which is approved to treat clot-based or ischemic strokes. It acts at sites of tissue injury and facilitates clotting, interacting with a substance called tissue factor.

Patients undergo a CT scan within three hours of symptom onset to help determine the source and size of the hemorrhage. Then, the stroke team has an hour to infuse the liquid. One day after treatment, a second CT scan shows the final size of the hemorrhage at 24 hours, which helps determine how well the drug worked. Blood samples are taken, and neurological exams are performed.

Researchers are currently in the process of a phase III trial, enrolling more than 600 patients. In a smaller, phase II trial, they found the drug limited size of hemorrhage growth. Patient mortality decreased, and patients had better outcomes.