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

Study Overview
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Brief Summary
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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).

Detailed Description
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Inclusion Criteria: The study population will be comprised of men and non-pregnant women age 18 years or older presenting with ICH or SAH that require ICP monitoring via ventriculostomy, and that require IV antihypertensive therapy to a) reduce the risk re-bleeding in SAH and b) reduce the risk of hematoma expansion over time due to further bleeding. This study population will require rapid and sustained tight control of blood pressure between 110 to 140 mmHg. Subjects may be included in the study if they meet all of the following criteria: 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 - 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 Exclusion Criteria: Subjects will be excluded from the study if any of the following exclusion criteria apply prior to enrollment: 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 Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.

Official Title
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The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Investigator Initiated Trial

Conditions
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Hypertension, Intracranial Hemorrhage, Subarachnoid Hemorrhage

Intervention / Treatment
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* Drug: Clevidipine butyrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clevidipine butyrate|Cleviprex will be administered according to current package insert instructions, with a starting dose of 2.0mg/hr for 1.5 minutes and thereafter titrated to lower blood pressure to a target goal of 110 mmHG to 140mmHG.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this trial is the time to achieve the pre-specified SBP target range (110-140) within 30 minutes of the initiation of Cleviprex infusion. |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion |  | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), intracranial monitoring, external ventricular drain (ventriculostomy), hypertension