Status:
COMPLETED
Antihypertensive Treatment in Acute Cerebral Hemorrhage
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Intracerebral Hemorrhage
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
An estimated 37,000 to 52,400 people in the United States have intracerebral hemorrhage (ICH) every year. ICH--a form of stroke that has poor outcome and is difficult to treat--is associated with the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00415610
Start Date
July 1 2005
End Date
March 1 2008
Last Update
November 21 2017
Active Locations (12)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
3
The University of Kansas School of Medicine, Wichita Via Christi Regional Medical Center
Kansas City, Kansas, United States, 66160
4
Massachusetts General/Brigham Women's Hospital
Boston, Massachusetts, United States, 02115