The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Investigator Initiated Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 30 minutes
次要结局
- The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion(30 minutes)