Status:
TERMINATED
Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage
Lead Sponsor:
Henry Ford Health System
Collaborating Sponsors:
The Medicines Company
Conditions:
Subarachnoid Hemorrhage
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study is designed to assess how rapidly and how safely Clevidipine can be used to control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain bleed that happens ...
Detailed Description
This is a single center, single-arm, non-blinded dose titration efficacy and safety trial evaluating the ability of clevidipine, a vascular-selective L-type calcium channel antagonist, to rapidly cont...
Eligibility Criteria
Inclusion
- Diagnosis of SAH
- Presence of unsecured aneurysm
- Patient age between 18 and 80 years
- Hunt and Hess grade \<5 (non-sedated-paralyzed pt)
- Glasgow Coma scale \>4 (non-sedated-paralyzed pt)
- BP above the pre-specified upper limit set by MD
- Patient has not received pressors or inotropes
- Patient has not received IV anti-hypertensives for more than 5 minutes (sodium nitroprusside infusion should be stopped as clevidipine is started
- Patient has given informed consent
Exclusion
- Patient is \<18 or \>80 years of age
- Patient has Traumatic SAH
- Patient has Perimesencephalic SAH
- Hunt and Hess grade 5 (deeply comatose/ brain dead)
- Glasgow Coma scale 3 or 4 (deeply comatose/brain dead)
- Patient on pressors or anti-hypertensives for more than 5 minutes
- SBP \< 90 mm Hg
- Heart rate \>110
- Patient with Left BBB
- Patient with a permanent ventricular pacemaker
- Known allergy to dihydropyridines or clevidipine
- Known allergy to soy products, beans, eggs or egg products22. Patients with defective lipid metabolism or pathologic hyperlipidemia or lipid nephrosis
- Acute pancreatitis, accompanied by hyperlipidemia
- Severe aortic stenosis
- Pregnancy
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00978822
Start Date
June 1 2009
End Date
December 1 2012
Last Update
March 2 2023
Active Locations (1)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202