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| Tracking Information | |||||||||||||||||||||||||
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| First Received Date ICMJE | April 30, 2008 | ||||||||||||||||||||||||
| Last Updated Date | October 8, 2009 | ||||||||||||||||||||||||
| Start Date ICMJE | April 2008 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: 5+ years ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00670735 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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. [ Time Frame: 5+ years ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN) | ||||||||||||||||||||||||
| Official Title ICMJE | HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN) | ||||||||||||||||||||||||
| Brief Summary | 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. The HCRN consists of five 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. |
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| Detailed Description | |||||||||||||||||||||||||
| Study Phase | |||||||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||||||||||||||||||
| Condition ICMJE | Pediatric Hydrocephalus | ||||||||||||||||||||||||
| Intervention ICMJE | |||||||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||||||
| Publications * | |||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 1400 | ||||||||||||||||||||||||
| Estimated Completion Date | December 2020 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 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:
Exclusion Criteria: The following temporary CSF diversion procedures will not be included in the Core Date Project: • External ventricular drain(s) |
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| Gender | Both | ||||||||||||||||||||||||
| Ages | up to 18 Years | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Canada | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT ID ICMJE | NCT00670735 | ||||||||||||||||||||||||
| Responsible Party | John Kestle, MD, Hydrocephalus Clinical Research Network | ||||||||||||||||||||||||
| Study ID Numbers ICMJE | 27896, HCRN 001 | ||||||||||||||||||||||||
| Study Sponsor ICMJE | University of Utah | ||||||||||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Utah | ||||||||||||||||||||||||
| Verification Date | October 2009 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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