跳至主要内容
临床试验/NCT00670735
NCT00670735招募中不适用

HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)

University of Utah14 个研究点 分布在 2 个国家目标入组 1,400 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,400
试验地点
14
主要终点
To describe the number and characteristics of neurosurgical hydrocephalus patient events to HCRN Clinical Centers such as patient demographics, etiology of hydrocephalus, diagnostic information, as well as surgical and medical management decisions.

研究概览

简要总结

The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. The HCRN consists of multiple Clinical Centers and the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all neurosurgical hydrocephalus events from the network Clinical Centers, and create a database to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two main purposes: 1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the HCRN. This multi-institutional database will be maintained throughout the lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over time. The Core Data Project will be an invaluable resource to the HCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Information for all neurosurgical hydrocephalus patient events will be obtained from each HCRN Clinical Center and will be placed continuously into the Core Data Project. The first calendar year will be 2008, and data collection will continue for the duration of the existence of the HCRN. Neurosurgical hydrocephalus patient events include any operation for the treatment of documented hydrocephalus including the following:
  • •Ventriculoperitoneal shunt
  • •Ventriculoatrial shunt
  • •Ventriculopleural shunt
  • •Arachnoid cyst shunts
  • •Subdural shunts
  • •Lumboperitoneal shunts
  • •Shunts replaced after treatment of infection
  • •Shunts exposed during an operations but not revised
  • •Endoscopic third ventriculostomies
  • •Ommaya reservoir(s)
  • •Ventricular access devices/reservoirs
  • •Subgaleal shunts.

排除标准

  • •The following temporary cerebrospinal fluid (CSF) diversion procedures will not be included in the Core Date Project:
  • •External ventricular drain(s)

结局指标

主要结局

To describe the number and characteristics of neurosurgical hydrocephalus patient events to HCRN Clinical Centers such as patient demographics, etiology of hydrocephalus, diagnostic information, as well as surgical and medical management decisions.

时间窗: 5+ years

次要结局

  • To provide this data to HCRN investigators to support hypothesis generation and study design development for clinical trials and observational studies to be carried out by the HCRN.(5+ years)

研究者

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

richard holubkov

Ph.D.

University of Utah

研究点 (14)

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