HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
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| ClinicalTrials.gov Identifier: NCT00670735 |
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Recruitment Status :
Recruiting
First Posted : May 2, 2008
Last Update Posted : November 4, 2022
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Sponsor:
University of Utah
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
richard holubkov, University of Utah
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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. 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 or disease |
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| Pediatric Hydrocephalus |
| Study Type : | Observational |
| Estimated Enrollment : | 1400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN) |
| Study Start Date : | April 2008 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hydrocephalus
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Pediatric Hydrocephalus patients.
Criteria
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 cerebrospinal fluid (CSF) diversion procedures will not be included in the Core Date Project:
• External ventricular drain(s)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670735
Contacts
| Contact: Marcie Langley | 801-662-5364 | marcie.langley@hsc.utah.edu |
Locations
| United States, Alabama | |
| Children's Hospital of Alabama, University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Anastasia Arynchyna, MPH 205-638-5018 arynch@uab.edu | |
| Principal Investigator: Curtis J Rozzelle, MD | |
| United States, California | |
| Children's Hospital of Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Christina Artime, BSN, MSHCM 323-361-7757 cartime@chla.usc.edu | |
| Principal Investigator: Mark Krieger, MD | |
| United States, Colorado | |
| Children's Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Susan Staulcup 303-724-5935 SUSAN.STAULCUP@UCDENVER.EDU | |
| Principal Investigator: Todd Hankinson, MD | |
| United States, Maryland | |
| Johns Hopkins Children's Center | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Adam Loudermilk 410-502-4031 alouder1@jhmi.edu | |
| Principal Investigator: Edward Ahn, MD | |
| United States, Missouri | |
| St. Louis Children's Hospital | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Mohamed Gabir 314-454-5498 mgabir@wustl.edu | |
| Principal Investigator: David Limbrick, MD, PhD | |
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Adrienne Boczar, MPH 614-722-8786 Adrienne.Boczar@nationwidechildrens.org | |
| Principal Investigator: Jonathan Pindrik, MD | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Kimberly Diamond, BS, BA 412-692-9965 Kldiamond@pitt.edu | |
| Principal Investigator: Mandeep S Tamber, MD, PhD | |
| United States, Tennessee | |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Deonte Dawson, BS 615-343-3251 deonte.dawson@vanderbilt.edu | |
| Principal Investigator: John C Wellons, III, MD, MSPH | |
| Principal Investigator: Chevis N Shannon, MBA, DrPH | |
| Principal Investigator: Robert Naftel, MD | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Sheila Martinez, BS 832-822-0653 srmarti2@texaschildrens.org | |
| Principal Investigator: William Whitehead, MD | |
| United States, Utah | |
| Primary Children's Hospital | Recruiting |
| Salt Lake City, Utah, United States, 84118 | |
| Contact: Jason Clawson, BA 801-662-5369 jason.clawson@hsc.utah.edu | |
| Principal Investigator: John Kestle, MD | |
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Gloria Bowen, MA 206-987-5916 gloria.bowen@seattlechildrens.org | |
| Contact: Amy Anderson, BSN, RN 206-987-5916 amy.anderson2@seattlechildrens.org | |
| Principal Investigator: Jason S Hauptman, MD, PhD | |
| Principal Investigator: Tamara D Simon, MD, MSPH | |
| Canada, Alberta | |
| Alberta Children's Hospital | Recruiting |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Contact: Salim Ahmed, MSc 403-955-5738 salahmed@ucalgary.ca | |
| Principal Investigator: Jay Riva-Cambrin, MD | |
| Canada, British Columbia | |
| British Columbia Children's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Alexander Cheong, BSc 604-875-2345 ext 7132 alexander.cheong@cw.bc.ca | |
| Principal Investigator: Patrick McDonald, MD | |
| Principal Investigator: Mandeep S Tamber, MD, PhD | |
| Canada, Ontario | |
| Sick Children's Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Homa Ashrafpour 416-813-7654 ext 328771 homa.ashrafpour@sickkids.ca | |
| Principal Investigator: Abhaya Kulkarni, MD, PhD | |
Sponsors and Collaborators
University of Utah
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
| Study Chair: | Jay Riva-Cambrin, MD | Alberta Children's Hospital | |
| Principal Investigator: | Abhaya Kulkarni, MD, PhD | Sick Children's Hospital, Toronto, Ontario | |
| Principal Investigator: | Tamara D Simon, MD, MSPH | University of Washington / Seattle Children's Hospital | |
| Principal Investigator: | Richard Holubkov, Ph.D. | University of Utah |
Additional Information:
| Responsible Party: | richard holubkov, Ph.D., University of Utah |
| ClinicalTrials.gov Identifier: | NCT00670735 |
| Other Study ID Numbers: |
27896 HCRN 001 ( Other Identifier: HCRN Protocol Number ) 1RC1NS068943-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 2, 2008 Key Record Dates |
| Last Update Posted: | November 4, 2022 |
| Last Verified: | November 2022 |
Keywords provided by richard holubkov, University of Utah:
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Pediatric Hydrocephalus |
Additional relevant MeSH terms:
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Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases |