Antihypertensive Treatment in Acute Cerebral Hemorrhage
Condition: Intracerebral Hemorrhage; Hypertension; Stroke
MeSH terms: Cerebral Hemorrhage; Hypertension; Hemorrhage
Intervention: nicardipine
Intervention description: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
Intervention MeSH terms: Nicardipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Staged intensity levels of rapid intravenous antihypertensive control for elevated SBP in patients with intracerebral hemorrhage were implemented in 3 sequential treatment arms to assess the feasibility and tolerability (safety) of this treatment.
Masking: None (Open Label)
Masking description: Open treatment assignment was employed because it is not safe to conceal SBP measurement. Patient data routinely entered by clinical staff were used to evaluate safety.
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cerebral hemorrhage; intracerebral hemorrhage; stroke; hypertension; blood pressure; nicardipine; antihypertensive agent; hematoma expansion

Summary:

      The purpose of this trial is to evaluate the safety and effectiveness of lowering blood
      pressure using nicardipine in persons with acute hypertension associated with intracerebral
      hemorrhage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age older than 18 years.

          -  Onset of new neurological signs of a stroke within 12 hours of the time to evaluation
             AND initiation of treatment with intravenous nicardipine.

          -  Clinical signs consistent with the diagnosis of stroke, including impairment of
             language, motor function, cognition, and/or gaze, vision, or neglect.

          -  The total GCS score is greater than 8 at the time of enrollment.

          -  CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement
             less than 60 cc.

          -  ICH is supratentorial and is located in lobar, basal ganglionic, or thalamic based on
             the initial CT scan appearance.

          -  Admission systolic blood pressure greater than 170 mm Hg on two repeat measurements at
             least 5 minutes apart.

          -  Evidence of chronic hypertension.

          -  Subject is not considered a surgical candidate by the neurosurgery service.

        Exclusion Criteria:

          -  Time of symptom onset cannot be reliably assessed.

          -  Previously known neoplasms, arteriovenous malformation, or aneurysms.

          -  Intracerebral hematoma considered to be related to trauma by the neurologist or
             neurosurgeon.

          -  ICH is located in the cortex or infratentorial regions such as pons or cerebellum.

          -  Blood is visualized in the subarachnoid space.

          -  Intravenous nicardipine cannot be initiated within 12 hours of symptom onset.

          -  Use of clonidine hydrochloride and other central alpha-agonist within the last 48
             hours that have the potential of withdrawal hypertension.

          -  Pregnancy, lactation, or parturition within previous 30 days.

          -  Any history of bleeding diathesis or coagulopathy, including the use of warfarin.

          -  Use of heparin in the previous 48 hours and a prolonged partial thromboplastin time.

          -  Known atrial-ventricular heart block other than first degree, or sick sinus syndrome
             without a pacemaker.

          -  Intolerance to calcium channel blockers.

          -  Exposure to study medication in the preceding 24 hours prior to enrollment.

          -  A platelet counts less than 100 000/mm3.

          -  Major surgery within the previous six weeks.

          -  History of any intracranial hemorrhage (including intracerebral or subarachnoid
             hemorrhage) or hemorrhagic stroke.

          -  Seizure at onset of stroke.

          -  Blood glucose less than 50 mg/dL or greater than 400 mg/dL.

          -  Current participation in another research drug treatment protocol.

          -  Isolated ventricular blood on CT scan.

          -  Subject has a living will that precludes aggressive intensive care unit management.

          -  Subject has acute myocardial infarction or renal failure that precludes use of
             aggressive antihypertensive therapy.

          -  Subjects with unstable angina or acute myocardial infarction within 2 weeks prior to
             ICH.

          -  Subjects with renal insufficiency with serum creatinine greater than 2.0 mg/dl or on
             renal dialysis.

          -  Sinus tachycardia exceeding 120 beats per minute or supraventricular tachycardia is
             observed during initial evaluation.

          -  Ischemic stroke within 4 weeks of presentation.

          -  Congestive heart failure graded as class III and IV by New York Heart Association
             (NYHA) classification.