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

• Status: Withdrawn
• Trial end date: 2010-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Methodist Healthcare
• Collaborator: The Medicines Company
• Treatments: Antihypertensive Agents; Clevidipine

Criteria

Inclusion Criteria:

1. Age 18 years or older

2. Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain.

3. Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured

4. Requires IV antihypertensive therapy to achieve SBP 110 to 140 mmHg

5. Patients with a life expectancy of > 5 hours.

6. Written informed consent from the patient or their legal representative before initiation of any study specific procedures

Exclusion Criteria:

1. Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex

2. Receipt of IV nicardipine

3. Glasgow coma score (GCS) of <5 and fixed dilated pupils

4. Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring

5. Known or suspected aortic dissection

6. Acute myocardial infarction (AMI) on presentation

7. Positive pregnancy test , known pregnancy or nursing mother

8. Intolerance or allergy to calcium channel blockers

9. Allergy to soybean oil or egg lecithin

10. Known liver failure, cirrhosis or pancreatitis

11. Defective lipid metabolism

12. Severe aortic stenosis

13. Prior directives against advanced life support

14. Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment