Hydrocephalus Clinical Research Network

HCRN Simplifies Shunt Surgery Protocol

john — Sat, 28 Jan 2012 07:34:12 +0000

Last summer, HCRN reported a reduced infection rate using a standardized protocol for shunt surgery¹. Since those data went for analysis, we have almost doubled the number of patients on the protocol (now over 3000). We recently reviewed the additional information and our protocol and we are making some changes. The new protocol will be shorter and simpler (which may further enhance compliance). Some steps have been removed and others added. We hope to analyze the new approach in about a year and see if we have further reduced shunt infection.

¹ Kestle J, Riva-Cambrin J, Wellons JC 3rd, Kulkarni AV, Whitehead WE, Walker ML, Oakes JM, Luerssen TG, Simon TD, Holubkov, for the Hydrocephalus Clinical Research Network: A standardized protocol to reduce cerebrospinal fluid shunt infection: The HCRN Quality Improvement Initiative. J Neurosurg Pediatr 8(1): 22-29

Summary of Semiannual HCRN Meeting

john — Tue, 06 Dec 2011 04:19:29 +0000

The semiannual HCRN meeting was recently held in Salt Lake City November 9th and 10th. For the first time we were joined by Gavin Reed who is the research associate at the Hydrocephalus Association. This meeting gave Gavin the opportunity to learn about HCRN and its studies and to represent HA at the meeting as part of our expanding partnership. The Core data project has now accumulated over 3000 events and plans for several analyses from this database were discussed. Several new projects were also considered. Chevis Shannon from Birmingham, having completed her PhD, is now on the Neurosurgery faculty — as such she presented an idea to study radiation exposure in IVH children. She was encouraged to develop a more detailed proposal for this interesting idea.

The infection protocol data were reviewed and possible changes to the protocol were discussed pending further analysis. Progress on Dr Riva-Cambrin’s “VINOH” study was reviewed. This study is funded by a Mentored Young Investigator award from the Hydrocephalus Association. The study examines neuropsychological outcomes in children with hydrocephalus. The collaboration with neuropsychologists is exciting and now a number of centers are entering patients. Finally the status of Dr. Jay Wellons’ study of Shunting Outcomes in Post Hemorrhagic Hydrocephalus and its pending NIH application was discussed. Excellent progress is being made and the grant will be reviewed in the New Year.

Plans are under way for the spring meeting in Houston.

HCRN Co-Founder Appointed to NINDS Advisory Council

john — Wed, 28 Sep 2011 06:18:21 +0000

Paul Gross, Chairman of Hydrocephalus Association’s (HA) Board of Directors, and, as you all know, a founding partner of the Hydrocephalus Clinical ResearchNetwork (HCRN), has been selected to join the National Advisory Neurological Disorders and Stroke Council, the main advisory panel to the National Institute of Neurological Disorders and Stroke (NINDS).

NINDS, a component of the National Institutes of Health (NIH), is the nation’s primary supporter of basic, translational and clinical research on the brain and nervous system. The NINDS Advisory Council is composed of physicians, scientists and representatives of the public, who review applications from scientists seeking support through government grants for biomedical research on disorders of the brain and nervous system. NINDS Advisory Council members also advise the NIH on research program planning and priorities.

“In just a few years, Mr. Gross has done a remarkable job of engaging engineers, scientists and clinicians in plans to develop research that will lead to better treatment for people with hydrocephalus,” said Story Landis, Ph.D., Director of the NIH National Institute of Neurological Disorders and Stroke (NINDS). “I am delighted that he will be a member of the NINDS Advisory Council and look forward to his participation.”

I am delighted as well and offer sincere congratulations to Paul on this appointment. Paul brings his entrepreneurial perspective, successful business experience, and a deep, passionate commitment to finding answers for people living with hydrocephalus.

Happy 5th Anniversary HCRN!

john — Mon, 12 Sep 2011 21:54:02 +0000

While everyone has been busy working away on HCRN studies and grant writing, HCRN’s 5th birthday quietly slipped by last month. This is a significant milestone that we should all be proud of. Our first meeting in the Neurosurgical office in Salt Lake was a small group, but we had big plans. Although optimistic, I wasn’t sure if we would succeed, so I am delighted that we continue to work together, grow and be productive five years down the road.

There have been many people who have worked hard to make this happen and keep it going. I would like to thank Paul Gross for his support and guidance, John Smith for his planning and writing abilities, the Executive Committee (Jim Drake, Tom Luerssen, Jerry Oakes, Jack Walker) for their counsel and guidance, and the investigators for enthusiastically supporting this endeavor and entrusting a significant portion of their academic growth to this infrastructure. Additionally of course, we wouldn’t be anywhere without our outstanding team of coordinators and our expert colleagues at the Data Coordinating Center. Last but not least, thank you to our donors who have made HCRN possible.

Thank you to everyone for your cooperative approach and hard work.

Happy 5th Birthday!

HCRN Investigators Visit NIH

john — Mon, 15 Aug 2011 04:18:35 +0000

HCRN investigators Wellons, Kestle, Holubkov, Riva Cambrin and Limbrick recently met with the Clinical Trials group at NINDS (NIH). The purpose of the meeting was to discuss plans for a randomized trial on the management of hydrocephalus in premature infants with intraventricular hemorrhage. The PI for the trial will be Dr Jay Wellons, from the Birmingham Alabama center. The HCRN team discussed the study plan with the staff at NINDS and received feedback and suggestions.

The meeting was great exposure for HCRN at the NIH and helped them refine the study plan. The goal is to apply for NIH funding for the trial later this year

HCRN Infection Study in the News

paul — Thu, 07 Jul 2011 04:26:48 +0000

Dr. Kestle’s research on the HCRN Shunt Protocol was published in the Journal of Neurosurgery: Pediatrics this month. Because of the potential impact of the study to reduce infection rates, the Journal has made the link to the article public. You can read the publication it is entirety here — A standardized protocol to reduce cerebrospinal fluid shunt infection: The Hydrocephalus Clinical Research Network Quality Improvement Initiative.

In addition to being published in the Journal of Neurosurgery, Dr. Kestle was interviewed by Medscape.com which published an article about the findings entitled Surgical Protocol Significantly Cuts Shunt Infection Rate This site has much broader readership in the medical community than just neurosurgeons so it is a very positive step in creating awareness for HCRN, its research and the protocol. The hope is that more hospitals will adopt the protocol and help decrease the shunt infection rate worldwide.

HCRN Publishes Lower Infection Rates

john — Thu, 02 Jun 2011 14:47:20 +0000

The longest running HCRN project has recently been accepted for publication in the Journal of Neurosurgery. The initial four HCRN centers (Primary Children’s Medical Center inSalt Lake City, Children’s Hospital of Alabama in Birmingham, Hospital for Sick Children in Toronto, and Texas Children’s Hospital in Houston) agreed on a standardized protocol for doing shunt surgery. The hypothesis of this quality improvement project was that reducing variation and standardizing the approach across centers would reduce the infection rate. It worked! The centers’ infection rate prior to the protocol was 8.8%, and it fell to 5.7% after the protocol was implemented. This study established initial collaboration and cooperation amongst the HCRN centers and has established a common baseline from which future studies can be launched.

A Glimpse Inside Our March 2011 Meeting

john — Thu, 21 Apr 2011 15:25:20 +0000

The HCRN recently held another highly successful semi-annual network meeting, returning to Birmingham, Alabama, where the local site treated members to their great southern hospitality. As the network has continued to grow in size and studies the time desired by the team to meet and discuss the current and proposed research and network infrastructure has also expanded. To make the most of the two days the HCRN meeting started the same afternoon that its members flew in from across the US and Toronto, Canada and seemed to go non-stop until members were saying goodbye at airport terminals.

That first afternoon was spent discussing several ideas for the first HCRN Randomized Controlled Trial. During the following days time was spent providing updates on ongoing studies such as The Registry and Infection Protocol which included discussions about possible differences at the sites in practice and making coding decisions. Jay Riva-Cambrin, one of the lead investigators for The Registry even gave an etiology coding quiz which site investigators and coordinators worked together to complete. These discussions showed that the HCRN continues to be dedicated to the highest quality and has not grown in the least bit complacent about studies that have been active since 2007 and 2008. To this end, the recent implementation of site monitoring in the network was also presented and discussed and reports are showing the visited sites to be well organized and the data entered to be highly accurate. The network has been very receptive to these visits and to implementing the few suggestions for improvement when they do occur.

Also discussed at the meeting were details around enrolling patients in the recently launched SOPHH study which is working to determine and standardize the best care for neonates with intraventricular hemorrhage and working through logistical issues in preparing to launch the next study (VINOH), which will look at neuropsychological outcomes in pediatric hydrocephalus patients. Results were provided for the Ultrasound Study which is now nearly complete and updates were provided on study proposals that were presented at the previous meeting.

The coordinators learned about the new software that the Data Coordinating Center will start using soon and discussed data collection to make sure everyone is up to date and consistent across the network. It was another energetic meeting for the HCRN and much was shared and accomplished. Thank you team Alabama for coordinating a successful event!

A New Test for Hydrocephalus?

john — Wed, 16 Mar 2011 01:36:04 +0000

The diagnosis of hydrocephalus and shunt malfunction can be difficult and often requires more information than can be provided by MRI, CT, or ultrasound. Our St Louis investigator, Dr David Limbrick has begun the search for biomarkers of hydrocephalus and shunt malfunction. He is testing CSF and blood from infants suffering from post-hemorrhagic hydrocephalus in order to identify proteins that can be used for early diagnosis. In addition these proteins may provide real-time feedback on the effectiveness of treatment. Ultimately, we hope that these or similar biomarkers will provide a tool to complement current imaging methods and facilitate the diagnosis and treatment of hydrocephalus.

Dr. Riva-Cambrin, Salt Lake City, receives HA Mentored Young Investigator Award

john — Fri, 21 Jan 2011 23:32:20 +0000

I am excited to announce that Jay Riva-Cambrin received one of two Mentored Young Investigator Awards from the Hydrocephalus Association this year. Jay’s project will investigate whether ventricle size is associated with neuropsychological outcomes. It will focus on school aged children (5-17 years) with a new diagnosis of hydrocephalus. They will have neuropsychology testing before their hydrocephalus is treated and six months afterward. In addition, the study will evaluate the neuropsychology tests. At present, there are a large number of tests that are complex and not easily used in clinical practice because they are expensive, time consuming and not specific to hydrocephalus. Dr. Riva-Cambrin’s study will determine whether these tests can be narrowed down, and identify the few most meaningful ones that can be used more efficiently with less expense and provide more specific information about hydrocephalus.

Prior to receiving the funding, Jay presented the study idea to the HCRN investigators. Regardless of funding, it was selected as a new HCRN project.

Congratulations Jay on getting this going and on receiving the HA Mentored Young Investigator Award!