After 6 hours the treating physician will make a determination to continue clinical management with cleviprex or another antihypertensive medication. As part of standard care, patients have their blood pressure monitored continuously. Once the SBP is lowered and is stable, the Cleviprex will be continued for 6 hours. If the SBP is still high, another medication used to treat high blood pressure will be added (Cardene or labetolol). The medication will be started at a low rate, and if the SBP still needs lowering, the dose increased every 90 seconds until the maximum FDA approved dose is reached. Informed consent will be sought from a surrogate (family member, spouse or close friend) according to Columbia University Medical Center guidelines.Ĭleviprex is fast acting and effects are seen in about 90 seconds. Due to the severity of their brain injury most of the patients eligible for the study will be unable to provide consent. The investigators will use Cleviprex to lower their SBP and record brain pressure and brain blood flow measurements from the multimodality monitoring. The treating physicians will have already had multimodality brain monitoring placed for clinical management of the patient (standard care). Patients who have an acute brain injury and who have severe high BP may benefit from this faster acting medication.įor this study, eligible patients, 18 yrs of age or older, will have been admitted to the Neurocritical care unit within 24 hours after their brain injury, who have high systemic (body) SBP. Cleviprex is given through an intravenous line (IV) and has the benefit of being faster acting and easier to control adjustments than other drugs used to treat high BP. Therefore lowering the blood pressure (BP) is critical, as continued bleeding occurs most frequently in patients with high BP.Ĭlevidipine Butyrate (Cleviprex) is a new medication approved by the FDA for the treatment of acute high blood pressure (hypertension). High systemic (body) blood pressure (SBP) may also increase the risk of ongoing bleeding. Several studies have suggested that high blood pressure is associated with a worsening outcome possibly due to an increased rate of continued bleeding or rebleeding, as well as increased brain swelling (cerebral edema). Patients with acute brain injury are at risk for complications such as increased pressure in the brain (intracranial pressure (ICP)), decreased blood flow, bleeding, and brain swelling (cerebral edema). Why Should I Register and Submit Results?.
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