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临床试验/NCT05970549
NCT05970549招募中不适用

DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
17
试验地点
1
主要终点
Residual blood volume

研究概览

简要总结

The purpose of this research study is to evaluate the safety and outcomes associated with the use of IRRAflow® System catheters in externally draining intracranial fluid to reduce intracranial pressure. This study will be comparing the IRRAflow® system to standard of care catheters used in the same procedure. The IRRAflow® system is FDA approved for this procedure.

详细描述

Intracranial hemorrhagic conditions can rapidly cause brain damage and often considered life- threatening. Of these, Intracerebral hemorrhagic (ICH) is the most common type of hemorrhagic stroke and is associated with higher rates of morbidity and mortality than all stroke subtypes.

Management of hemorrhagic patients is typically orchestrated by neurosurgeons and neuro-intensivists. Comprehensive care should include surveillance and monitoring of Intra Cranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and hemodynamic function. Furthermore, prevention of infection, complications of immobility through positioning and mobilization within physiological tolerance play an important role in optimizing outcomes after ICH.

There are multiple approaches to facilitating Cerebrospinal Fluid (CSF) drainage and monitor ICP. Routinely, intracranial pressure is measured by use of devices inserted into the brain parenchyma or cerebral ventricles. A Ventricular Catheter (VC) inserted into the lateral ventricle allows for drainage of CSF to help reduce ICP. Although CSF drainage is a vital sequence in patient management, there are reported risks including infection and limitations related to erroneous readings associated with current ICP monitors. Physicians lack the appropriate tools to employ active intermittent aspiration and drainage with continuous ICP monitoring.

The current clinical study is being initiated to evaluate the hypothesis that active irrigation by IRRAflow will reduce the time needed for clearance of intraventricular blood from intraventricular space.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

There will be no masking involved. The proposed study is a single center retrospective and prospective cohort, controlled, single-center, phase 1 study evaluating the safety and radiographic outcomes associated use of the IRRAS catheter compared to standard of care external ventricular drains.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >=18 years of age
  • Intraventricular hemorrhage documented on head CT or MRI scan
  • Need of cerebrospinal fluid drainage
  • Indication for active treatment evaluated by the treating physicians
  • Signed informed consent obtained by patient or Legal Authorized Representative
  • Treatment possible within 72 hours of ictus

排除标准

  • Patient has fixed and dilated pupils
  • Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)

研究组 & 干预措施

Retrospective analysis of traditional external ventricular drains

Active Comparator

The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

干预措施: Traditional extraventricular drain (Device)

IRRAflow with Active Fluid Exchange arm

Experimental

The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.

干预措施: IRRAflow® Active Fluid Exchange System (Device)

IRRAflow with Active Fluid Exchange arm

Experimental

The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.

干预措施: Non-contrast head CTs (Procedure)

结局指标

主要结局

Residual blood volume

时间窗: At day 5

Residual blood volume on post bleed day 5

次要结局

  • Hospital quality metrics(up to 48 hours post-procedure)
  • Length of stay in the NSICU(up to 48 hours post-procedure)
  • Serious adverse events(up to 48 hours post-procedure)
  • Direct hospitalization costs(up to 48 hours post-procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher P Kellner

Assistant Professor in Neurosurgery

Icahn School of Medicine at Mount Sinai

研究点 (1)

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