NETT-WorkiNgs NEurological EmErgENciEs TrEaTmENT Trials (NETT) NETWork

march 2015

University of California, San FranciscoJ. Claude Hemphill, III, MD

New York Presbyterian HospitalStephan Mayer, MD

University of CincinnatiArthur Pancioli, MD

University of MarylandBarney J. Stern, MD

University of MinnesotaMichelle Biros, MD, MS

University of PennsylvaniaJill Baren, MD, MBEUniversity of Texas

Elizabeth Jones, MDVirginia Commonwealth University

Joseph P. Ornato, MDWayne State University

Robert Welch, MD University of California, Los Angeles Jeffrey Saver, MD and Sidney Starkman, MD Ohio State University Michel Torbey, MD

Emory UniversityDavid Wright, MDHenry Ford Health System Christopher Lewandowski, MDMedical College of Wisconsin Tom Aufderheide, MDUniversity of KentuckyRoger Humphries, MD and Creed Pettigrew, MDOregon Health & Science UniversityRobert Lowe, MD, MPH and Craig Warden, MDUniversity of PittsburghClifton Callaway, MD, PhD and Jon Rittenberger, MDTemple University Nina Gentile, MDUniversity of Arizona Kurt Denninghoff, MDSUNY Downstate Medical Center Steven Levine, MDMassachusetts General HospitalJoshua N. Goldstein, MD, PhDStanford University James V. Quinn, MD

cliNical coordiNaTiNg cENTEr (ccc) University of MichiganWilliam Barsan, MD

National Institute of Neurological Disorders and Stroke (NINDS)

Clinical Trial GroupRobin Conwit, MD and Scott Janis, PhD

sTaTisTical & daTa maNagEmENT cENTEr (sdmc) Medical University of South Carolina

Yuko Palesch, PhD

ParTiciPaTiNg hubs aNd iNvEsTigaTors

Enrollment Update: As of 4-1-15 at 11:01a (EDT) POINT SHINE

Arizona <5 43 4 Cincinnati <5 120 16 Emory 7 62 61 HFH 7 49 <5 Kentucky <5 45 32

Maryland <5 39 9 Mass General 17 28 6 Minnesota 28 110 9 NYP 26 49 71 Ohio State <5 18 (Emmes/NETT) 42

OHSU <5 51 <5 Pittsburgh <5 18 24 SUNY Downstate 9 48 8

Stanford 13 86 16

Temple 10 63 24 Texas 17 82 27 UCLA <5 25 (Emmes/NETT) 8 UCSF <5 59 8 UPenn 34 226 20 VCU <5 12 <5 Wayne State <5 121 12 Wisconsin <5 60 9 Non NETT sites (ATACH-II only) 489 - - Emmes + Harrison (POINT only) - 1335 - Ancillary Sites (SHINE only) - - 145 TOTAL 853 2712 559

ATACH-II

Jaideep Kapur, MBBS, PhDESETT Principal Investigator

Dr. Kapur is the Eugene Meyer III Professor of Neuroscience, Professor of Neurology & Director of Neuroscience Center of Excellence at the University of Virginia. Dr. Kapur provides care to epilepsy patients as a member of the FE Dreifuss Comprehensive Epilepsy Program. He has a long-standing interest in understanding the neurobiological mechanisms underlying prolonged self-sustaining seizures. His laboratory studies rapid plasticity of GABA and glutamate-mediated neurotransmission. Another area of research is regulation of seizures by hormonal fluctuations. Dr. Kapur served as the President of the American Epilepsy Society in 2010. He has served on numerous grant review panels for NIH, CURE Epilepsy Foundation, Epilepsy Foundation, and Epilepsy Research Foundation. He is the recipient of the 2013 Epilepsy Research Recognition Award for Basic Science conferred by the American Epilepsy Society.

Jim Chamberlain, MDESETT Principal InvestigatorDr. Chamberlain was born in a very small town (1200 population) outside Worcester, MA. He grew up in Massachusetts, but never quite got the hang of the accent. In high school, he got really jazzed by science because of a couple amazing teachers. College was at Rensselaer, an engineering college in upstate, NY, where he spent a lot of time playing intramural hockey and learning the scientific method. He then went to the University of Connecticut School of Medicine, where he met his law-student wife at a Halloween party. They then moved to the Washington, DC area for his residency at the University of Maryland and fellowship in DC. They have been there since. In fellowship he became interested in clinical research, and it’s been all downhill since. He works with a talented group of people (pictured above). His areas of interest are seizures, quality assessment, and health services research.

Kate ShreveESETT PECARN Nodal AdministratorKate is the Clinical Research Program Manager for the Division of Emergency Medicine at Children’s National Health System in Washington, DC and a Nodal Administrator for the Pediatric Emergency Care Applied Research Network (PECARN). She earned a BA in History and Community Health from Brown University and an MPH in Epidemiology/Biostatistics from George Washington University. Kate’s research experience includes coordinating pediatric HIV drug trials in New York, building a state agency to fund stem cell research in California, and Emergency Medicine research. She lives in DC, where she grew up, with her musician/software engineer husband and 2 children (ages 5 and 3). Kate spends all her time outside of work trying to keep up with her young kids—hiking in the woods; building forts, art projects and lego spaceships; cooking, playing music and putting on plays (luckily, for imaginary audiences); and learning how to skateboard (badly). She is thrilled to get the chance to work with the outstanding NETT team on the ESETT Study.

Pleased to Meet You NETT...

SHINE Informed Consent Training and Vignettes Video

THE SHINE team has developed an informed consent process video as a training tool for sites. The video features tips on explaining the study, including segments on finger sticks and the protocol diet, as well as elements of a good informed consent practice. The video can be found in the Education and Training section of the study web-site. We welcome you to review it with your teams.

Welcome (Back) to SHINE Brent Freeman

The SHINE leadership team is delighted to welcome Brent Freeman back to SHINE. Brent has been involved in clinical research for almost two decades. Many of you may know Brent from his role at Temple University as the NETT Hub Project Manager before leaving that position to join his wife in Miami where she is completing her degree. He is excited to once again be working with the NETT and SHINE teams as a Project Manager for SHINE at the Univer-sity of Virginia. When he is not at work Brent enjoys hiking, running, reading, and fly fishing. Since living in Miami Beach he has become quite fond of the ocean and spending time at the beach.

Retention Tip - SHINE and the mRS

The modified Rankin Scale (mRS) score is assessed at the 6-week (by phone) and 90-day (in person) visits for SHINE. The goal is to have 100% retention in the trial with all outcomes assessed by a blinded team member. However, when in window, we would recommend assessing and documenting the mRS by phone when calling with appointment reminders or when, otherwise, in communication with the patient and/or caretaker – even if the study team member is unblinded. This would mean that there is a documented mRS in window in the event the subject later becomes lost to follow up. Questions about retention and follow-up visits should be directed to Katrina van de Bruinhorst.

Site Update

Washington Hospital Center is the most recent SHINE site released to enrollment. Congratulations to Dr. Benson and Preethy Feit and the WHC team. This is the second StrokeNet site to be activated in SHINE. The first was North-western in July 2014. -Amy Fansler (ACF7H@hscmail.mcc.virginia.edu)

Stroke Hyperglycemia Insulin Network Effort Trial

Principal Investigators: Karen Johnston, MD, MSc, Askiel Bruno, MD, and Christiana Hall, MD

NETT Network Contact Us: nett-contact@umich.edu (734) 232-2142 Website: http://nett.umich.edu

Next NETT Journal Club Join us on April 15th

at 1:00 pm EDTJournal topics for each month can be found on the NETT

website at: http://nett.umich.edu/nettjournalclub

Platelet-Oriented Inhibition in New TIA TrialPrincipal Investigator: Clay Johnston, MD

Biomarker Study Kits

Please check your current inventory of POINT Biomarker Study kits and be sure to regularly track the expiration dates of your supplies. Expired kits must be destroyed per local guidelines. Sites can order new kits directly from LabCorp using the Supply Reorder Form (Appendix 6 of the LabCorp Clinical Trials Manual). Please see the Ancillary Biomarker Study FAQs on the POINT website for more details. -Renee Kasperek-Wynn (kasperr@umich.edu)

A BIG thank you to all sites for working hard to meet the submission tar-gets for the EFIC proposals and study applications to IRBs. As of March 27, 2015, six NETT hubs and two PECARN sites have received approval to start EFIC activities. As local IRBs continue to review applications, some IRBs may have questions or contingencies. The ESETT team will be glad to assist site teams with drafting responses. If there are other ways that we can help with readiness, feel free to reach any one of us.If a NETT hub would like to bring up another spoke, kindly email the

esett-milestone@umich.edu address with spoke’s official name, official address, PI and PSC name and contact information. This helps the site managers track upcoming sites while the ESETT database is developed.

Investigator Meeting - Save the Date

Please save the dates for the ESETT Investigator Meeting – September 17 and 18, 2015. A save the date email was sent as well. We hope to meet site teams in person soon. Stay tuned, more info will follow soon.

FAQs and Slide Deck for Clinical Staff

FAQs with responses are posted on the ESETT.org website under ESETT FAQs. A slide deck is also posted in the Toolbox under ESETT Overview to facilitate ESETT study discussion with clinical staff.