A patient is brought into the ER by his family. They were having breakfast together when they noticed Dad’s speech started to slur and he wasn’t making sense. Soon he couldn’t move his right arm and when he tried to get up, he couldn’t walk.
Physicians in the ER recognize that this patient is having a stroke. They have to act fast!
Before they can do anything though, they have to find out what kind of stroke he is having; the kind caused by a bleed or the kind caused by a blood clot. This is important because the treatments are different and treating the wrong kind of stroke can be deadly.
If the stroke is caused by a blood clot (called an ischemic stroke), doctors can use drugs to thin the blood and dissolve the clot. If the stroke is caused by a bleed (called a hemorrhagic stroke) these same drugs can cause the bleeding to worsen.
Doctors can find out what kind of stroke a patient is having by getting a CT scan. If the stroke is caused by a bleed in the brain, the CT scan will pick up a hematoma, a bruise or an area where blood has spread out in the brain.
The location and size of the hematoma are measured and generally speaking, the larger the hematoma, the worse the brain bleed. The likelihood of survival and the level of disability the stroke causes depends on how big the bleed is as well as its location within the brain. The goal of treatment is to stabilize the patient and to stem the bleeding as much as possible. Unfortunately, success rates for this kind of stroke are no where near the level they are for ischemic strokes. For this reason, their treatment is the subject of an aggressive push in the field of research to find better treatments.
For years, physicians have noticed that patients with a brain bleed also often have a large spike in their blood pressure (BP). That is, about 75% of these patients have acute hypertension. It is easy to imagine that with higher blood pressure, bleeding could progress more quickly and cause more damage. For this reason, the National Institute of Neurological Disorders and Stroke (NINDS) and the Stroke Council of the American Heart Association have recommended an increase in clinical trials specifically looking at drugs that can lower blood pressure during this critical time.
Dr. Dorothea Altschul and Dr. E. Sander Connolly are part of an international group conducting a five year, international, multi-center trial officially titled, Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II). This trial is looking at the drug Nicardipine hydrochloride, also called Cardene®, for patients suffering a cerebral hemorrhage, or bleeding in their brain.
The study will recruit up to 1,280 subjects at 86 study locations across the US and Asia. Locations include St. Josephs Regional Medical Center in Paterson, New Jersey where Dr. Altschul is one of the study investigators, and Columbia University Medical Center/New York Presbyterian Hospital in New York City where Dr. Connolly is an investigator.
Patients are chosen for inclusion in this study if they arrive at a participating medical center within 4.5 hours of the onset of a hemorrhagic stroke. Their symptoms may include difficulty speaking; impairment of motor function, cognition, gaze, and/or vision; or neglect of one side of their bodies. A CT scan is taken to confirm the presence of a hematoma.
Cardene® is given via an IV drip within the first 4.5 hours of symptom onset to bring blood pressure down to a normal level. This particular BP lowering drug was chosen because it is known to be most effective on blood vessels within the brain. Patients will have a second CT scan before they leave the hospital to compare any changes in the size of the hematoma.
Patients in this study are followed for three months to see how they recover. Their outcomes will be compared to patients who have not been treated with the drug. Researchers will be looking at survival rates among these patients as well as their functional ability or level of disability. In this phase III trial researchers are hoping to see a significant improvement in patients who are given the drug. Their summary of the importance of this trial is below:
The proposed trial will have important public health implications by providing necessary information regarding the efficacy and safety of antihypertensive treatment of acute hypertension observed in up to 75% of the subjects with ICH. BP treatment represents a strategy that can be made widely available without the need of specialized equipment and personnel and therefore can make a major impact upon outcome in patients with ICH.–clinicaltrials.gov
Learn more about this clinical trial here.
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