The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy

Withdrawn before enrolling · Phase 4

Conditions studied: Hypertension, Intracranial Hemorrhage, Subarachnoid Hemorrhage

In brief

This study is a single-arm, open label protocol evaluating the use of Cleviprex to rapidly control hypertension in patients who present with intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH), and that require ICP monitoring via ventriculostomy (External Ventricular Drain or EVD).

Key facts

Study ID

NCT01042574

Run by

Methodist Healthcare - Memphis

People needed

0

Starts

2010-05-01

Expected to finish

2010-12-31

Last updated by the study team

2019-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain.
• Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured
• Requires IV antihypertensive therapy to achieve SBP 110 to 140 mmHg
• Patients with a life expectancy of > 5 hours.
• Written informed consent from the patient or their legal representative before initiation of any study specific procedures

You may not qualify if…

• Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex
• Receipt of IV nicardipine
• Glasgow coma score (GCS) of <5 and fixed dilated pupils
• Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring
• Known or suspected aortic dissection
• Acute myocardial infarction (AMI) on presentation
• Positive pregnancy test , known pregnancy or nursing mother
• Intolerance or allergy to calcium channel blockers
• Allergy to soybean oil or egg lecithin
• Known liver failure, cirrhosis or pancreatitis
• Defective lipid metabolism
• Severe aortic stenosis
• Prior directives against advanced life support
• Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment

Where it is running

• Methodist Healthcare, University Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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