Status:
WITHDRAWN
Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®)
Lead Sponsor:
University of Zurich
Conditions:
Nontraumatic Intracerebral Hemorrhage, Multiple Localized
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Intracerebral hemorrhage (ICH) is responsible for 10-15% of primary strokes. ICH is a dynamic process with three phases: initial hemorrhage, followed by hematoma expansion and perihematoma edema forma...
Detailed Description
After admission to the ICU the patients presenting with primary intracerebral hemorrhage (ICH) are evaluated for enrollment. If systolic blood pressure (SBP) is higher than 160 mmHg or SBP \<160 mmHg ...
Eligibility Criteria
Inclusion
- Primary intracerebral hemorrhage (ICH)
- Systolic blood pressure (SBP) \> 160 mmHg at screening
- Systolic blood pressure (SBP) \<160 mmHg under intravenous antihypertensive drug (e.g. Urapidil), started less than 3 h before randomization
- 18 to unlimited years of age
- Signed informed consent obtained
Exclusion
- Patients with secondary hemorrhage (bleeding source as aneurysm, arteriovenous malformation or traumatic)
- Patients with concomitant severe critical illness (e.g. sepsis, multi-organ failure)
- Positive pregnancy test for any female of childbearing potential or breast feeding female
- Known allergy to any component of Clevidipine (Cleviprex®), Urapidil Ebrantil®), soya bean oil or severe egg protein allergy
- Contraindications for Clevidipine (Cleviprex®): defect in the lipid metabolism, critical aortic stenosis
- Contraindications for Urapidil (Ebrantil®): aortic coarctation, arterio-venous shunt, breastfeeding period
- Patients with pre-existing disability and legal representative
- Patients participating in a interventional clinical trial within the last 30 days before Start of Treatment
Key Trial Info
Start Date :
June 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03300479
Start Date
June 15 2017
End Date
May 14 2021
Last Update
November 8 2021
Active Locations (1)
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1
University Hospital Zurich
Zurich, Switzerland, 8091