HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
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Purpose
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.
| Condition |
|---|
|
Pediatric Hydrocephalus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN) |
- 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 ]
- 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 ]
| Estimated Enrollment: | 1400 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pediatric Hydrocephalus patients.
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:
- 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.
Exclusion Criteria:
The following temporary CSF diversion procedures will not be included in the Core Date Project:
• External ventricular drain(s)
Contacts and Locations| Contact: Marcie Langley | 801-662-5364 | marcie.langley@hsc.utah.edu |
| United States, Alabama | |
| Children's Hospital of Alabama, University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Amita Bey, MPH 205-939-9474 Amita.Bey@chsys.org | |
| Principal Investigator: Jay Wellons, MD | |
| Sub-Investigator: Chevis N Shannon, MBA, DrPH | |
| United States, Missouri | |
| St. Louis Children's Hospital | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Deanna Mercer 314-454-5498 mercerd@wudosis.wustl.edu | |
| Principal Investigator: David Limbrick, MD, PhD | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Arlene M Luther, BS RN 412-692-9965 luthera@upmc.edu | |
| Principal Investigator: Mandeep S Tamber, MD, PhD | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Sheila Ryan, MPH, JD 832-822-4074 slryan@texaschildrens.org | |
| Principal Investigator: William Whitehead, MD | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84118 | |
| Contact: Tracey Bach, BS 801-662-5344 tracey.bach@hsc.utah.edu | |
| Principal Investigator: Jay Riva-Cambrin, MD | |
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Amy Anderson, BSN, RN 206-987-5916 amy.anderson2@seattlechildrens.org | |
| Principal Investigator: Samuel R. Browd, M.D., Ph.D. | |
| Canada, Ontario | |
| Sick Children's Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Megha Agarwal 416-813-7600 ext 28771 megha.agarwal@sickkids.ca | |
| Principal Investigator: Abhaya Kulkarni, MD, PhD | |
| Study Chair: | Jay Riva-Cambrin, MD | Primary Children's Medical Center |
| Principal Investigator: | William Whitehead, MD | Texas Children's Hospital |
| Principal Investigator: | Jay Wellons, MD | Children's Hospital of Alabama, University of Alabama |
| Principal Investigator: | Abhaya Kulkarni, MD | Sick Children's Hospital, Toronto, Ontario |
| Principal Investigator: | Samuel R. Browd, M.D., Ph.D. | Seattle Children's Hospital |
| Principal Investigator: | Tamara D Simon, MD, MSPH | University of Washington / Seattle Children's Hospital |
| Principal Investigator: | David Limbrick, MD, PhD | St. Louis Children's Hospital |
| Principal Investigator: | Mandeep S Tamber, MD, PhD | Children's Hospital of Pittsburgh of UPMC |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00670735 History of Changes |
| Other Study ID Numbers: | 27896, HCRN 001, 1RC1NS068943-01 |
| Study First Received: | April 30, 2008 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
Pediatric Hydrocephalus |
Additional relevant MeSH terms:
|
Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases Intracranial Hypertension |
ClinicalTrials.gov processed this record on May 16, 2013