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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00670735
Recruitment Status : Recruiting
First Posted : May 2, 2008
Last Update Posted : November 4, 2022
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
richard holubkov, University of Utah

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
Pediatric Hydrocephalus

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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 :
  1. 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 :
  1. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT00670735

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Contact: Marcie Langley 801-662-5364

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United States, Alabama
Children's Hospital of Alabama, University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Anastasia Arynchyna, MPH    205-638-5018   
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   
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   
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   
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   
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   
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   
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   
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   
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   
Contact: Amy Anderson, BSN, RN    206-987-5916   
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   
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   
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   
Principal Investigator: Abhaya Kulkarni, MD, PhD         
Sponsors and Collaborators
University of Utah
National Institute of Neurological Disorders and Stroke (NINDS)
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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:
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Responsible Party: richard holubkov, Ph.D., University of Utah 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:
Pediatric Hydrocephalus
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases