The evaluation of patients with acute hypertension and intracerebral hemorrhage with intravenous clevidipine treatment - ACCELERATE

The Medicines Company0 个研究点目标入组 60 人开始时间: 2008年3月14日最近更新: 2012年9月3日

适应症

试验速览

暂无简介。

•1. CT evidence of intracerebral hemorrhage (diagnosis within 6 hours of symptom onset)
•2. Age 18 years or older
•3. Baseline systolic blood pressure (SBP) (immediately prior initiation of clevidipine) > 160 mm Hg measured using an arterial line
•4. Requires antihypertensive therapy to achieve SBP less than or equal to 160 mm HG
•5. Written informed consent from the patient or their legal representative before initiation of any study-related procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Decision for early surgical evacuation (e.g. large cerebellar or lobar hemorrhage)
•2. Receipt of an oral hypertensive within 2 hours prior to initiation of clevidipine
•3. Treatment with a continuous infusion of an intravenous (IV) antihypertensive agent prior to initiation of clevidipine. Bolus treatment with labetalol or hydralazine is permitted
•4. Intracerebral hematoma considered to be related to trauma by neurologist or neurosurgeon
•5. Aneurysmal sub-arachnoid hemorrhage
•6. Glasgow coma score < 5 and fixed dilated pupils
•7. Expectation that the patient will not tolerate or require intravenous antihypertensive therapy for a minimum of 30 minutes
•8. Coagulopathy (INR >1.3 at screening)
•9. Known or suspected aortic dissection
•10. Acute myocardial infarction (AMI)
•11. Positive pregnancy test or known pregnancy
•12. Intolerance or allergy to calcium channel blockers
•13. Allergy to soybean oil or egg lecithin
•14. Known liver failure, cirrhosis or pancreatitis
•15. Prior directives against advanced life support
•16. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment

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