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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Hydrocephalus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pediatric Hydrocephalus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

richard holubkov

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jay Riva-Cambrin, MD

Role: STUDY_CHAIR

Alberta Children's Hospital

Abhaya Kulkarni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sick Children's Hospital, Toronto, Ontario

Tamara D Simon, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington / Seattle Children's Hospital

Richard Holubkov, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HCRN 001

Identifier Type: OTHER

Identifier Source: secondary_id

1RC1NS068943-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

27896

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

University of Utah

Responsible Party

richard holubkov

Principal Investigators

Jay Riva-Cambrin, MD

Abhaya Kulkarni, MD, PhD

Tamara D Simon, MD, MSPH

Richard Holubkov, Ph.D.

Locations

Children's Hospital of Alabama, University of Alabama

Children's Hospital of Los Angeles

Children's Hospital Colorado

Johns Hopkins Children's Center

St. Louis Children's Hospital

Nationwide Children's Hospital

Children's Hospital of Pittsburgh of UPMC

Monroe Carell Jr. Children's Hospital at Vanderbilt

Texas Children's Hospital

Primary Children's Hospital

Seattle Children's Hospital

Alberta Children's Hospital

British Columbia Children's Hospital

Sick Children's Hospital

Countries

Central Contacts

Marcie Langley

Facility Contacts

Anastasia Arynchyna, MPH

Curtis J Rozzelle, MD

Christina Artime, BSN, MSHCM

Mark Krieger, MD

Susan Staulcup

Todd Hankinson, MD

Adam Loudermilk

Edward Ahn, MD

Mohamed Gabir

David Limbrick, MD, PhD

Adrienne Boczar, MPH

Jonathan Pindrik, MD

Kimberly Diamond, BS, BA

Mandeep S Tamber, MD, PhD

Deonte Dawson, BS

John C Wellons, III, MD, MSPH

Chevis N Shannon, MBA, DrPH

Robert Naftel, MD

Sheila Martinez, BS

William Whitehead, MD

Jason Clawson, BA

John Kestle, MD

Gloria Bowen, MA

Amy Anderson, BSN, RN

Jason S Hauptman, MD, PhD

Tamara D Simon, MD, MSPH

Salim Ahmed, MSc

Jay Riva-Cambrin, MD

Alexander Cheong, BSc

Patrick McDonald, MD

Mandeep S Tamber, MD, PhD

Homa Ashrafpour

Abhaya Kulkarni, MD, PhD

Related Links

Other Identifiers

HCRN 001

1RC1NS068943-01

27896