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January 2017

New Trials Begin

SEPSIS-ACT

Led by Hyung Kim (PI) with overall coordination in Denmark, SEPSIS-ACT (Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive    Clinical Trial) is a multicenter Phase IIb/III adaptive trial to investigate whether selepressin increases vasopressor and ventilator-free days compared with placebo in septic shock. Selepressin is vasopressin analogue with selective V1a receptor agonist activity, and mitigates vascular leak. In animal studies and early clinical trials, selepressin was associated with less lung edema and lower cumulative fluid balance than vasopressin. We anticipate going live by Mid-January. Denise Scholl and Tina Vita are the lead coordinators.


LITES

Linking Investigation in Trauma & Emergency Services Clinical Research Network

MACRO to Provide Clinical Coordination Center Service to Pitt-led, Department of Defense Trauma Research Network

The complete article available here.


STONE

The trial of tamsulosin for urolithiasis in the emergency department (STONE), recently completed enrollment in the emergency departments of Presbyterian and Mercy  Hospitals. Allan Wolfson is the local Principal Investigator and the Co-Investigator is Stephen Jackman.  Of the 350 study enrollments, MACRO Research Associates helped to enroll 101 subjects into the study with our emergency medicine physicians.

STONE is a placebo-controlled, two-armed trial to determine the effectiveness of tamsulosin on patients passing a kidney stone. Currently, there is no RCT evidence showing that Flomax speeds the passage of stones. Participating patients were randomly assigned to take Flomax or a placebo for thirty days, complete several study phone calls and return to the ED for a follow up CT scan. Check future newsletters for updates on study findings as the data analysis is undergoing.

 

 

Meet Our New CRC - Caroline Gaka

 

Caroline, a native of Pittsburgh, grew up in the North Hills of Pittsburgh. She attended Wheeling Jesuit University in Wheeling, WV, and obtained her BSN. Upon passing the boards, Caroline moved to Morgantown to work at Ruby Memorial Hospital as a nurse on a neurosurgery unit. From there she worked at UPMC Passavant on their neurosurgery post-op floor. Caroline is now starting her career with MACRO as a Clinical Research Coordinator. Some of her many interests include, reading, playing soccer, snowboarding, travelling, and doing many different types of crafts. When she is not at home with her two cats, she is travelling with her family throughout the country and abroad.

 

Meet Our New Regulatory Coordinator - Kathleen Kelly

Kathleen was born and raised in NE, Ohio but spent most of her adulthood in Manhattan, as well as a few years in the Southwest and Pacific Northwest.  She began her career as a Professional Organizer, Event Planner and Bookkeeper.  Currently, she is working in MACRO as a temporary project and financial assistant.  Kathleen has a BS in Behavioral Science and a certificate in Bookkeeping from NYU.  An avid traveler, she has visited every state but Alaska and a total of nine countries.  Kathleen has volunteered for many animal rescues and shelters; her largest foster experience was caring for  nine -  6 week-old terrier mix puppies for several weeks.  She enjoys yoga, meditation, cooking, knitting and scratching as many items off her bucket list as she can.

 

Student RA Turned Full-Time - Megan Buhay

Megan started working for the Multi-Disciplinary Acute Care Research Organization (MACRO) as a student research assistant in the Fall of 2012. While earning her Bachelors of Science in Psychology and  Bachelor of Arts in Physical Anthropology at the University of Pittsburgh, she worked for MACRO and is very excited at the opportunity to continue to contribute to the organization as a full-time staff member.  She currently co-manages our Research Associate Intern program and our Research Specialist program, while providing oversight to MACRO’s division at UPMC Mercy, carrying out various research protocols, as well as executing and maintaining medical data abstraction  projects.  She is a member of the Association of Clinical Research Professionals (ACRP). When she is not working, Megan loves finding ways to stay active, such as bike riding and rock climbing.  Her most recent adventure was a 330 mile bike ride from Pittsburgh to Washington, D.C.!

 

 

MACRO Research Associate Interns

MACRO’s Research Associate Intern’s (RAI), a team of dedicated Pitt undergraduates, screen the UPMC Presbyterian ED 24/7/365 for  approximately ten studies at any given time. Among the ED based studies, four focus on trauma: PAMPer, STAAMP, Mathematical Modeling, and TTMR. The RAIs carry a trauma pager and meet every trauma in the trauma bay simultaneously with the trauma team to assess the patient’s eligibility for study enrollment. In the case of PAMPer and STAAMP, patients are enrolled by STAT MedEvac and receive the study intervention while en route to UPMC Presbyterian.

Thanks to the RAIs and our close collaboration with STAT MedEvac. Pitt is the #1 enrolling site for both PAMPer and STAAMP. The RAIs successfully enrolled or facilitated the enrollment of over 340 trauma patients since 5/1/2016.

 

A Fond Farewell

Mitch Moyer

Mitch is now working within the Lab of Neuropsychology (LN) at NIMH (National Institute of Mental Health) as an  IRTA (Intramural    Research Training Award) Post-baccalaureate. His main project is examining behavioral effects from lesioning different fornix and fornix target regions focusing on monkey learning ability and memory. He will be a surgical assistant during surgeries and will be running    monkeys through their behavioral tests.  He potentially will assist with any neuroanatomical work that needs done post-mortem (histology, microscopy, etc.) on monkeys across all their projects.

 

 

May 2016

ARDS Trials at Pitt

START

Lead by Drs. Bryan McVerry and Michael Donahoe (PI) with overall coordination in UCSF, START (STem cells for ARDS Treatment) is a multicenter Phase II trial to explore the use of human bone marrow derived mesenchymal stem cells for ARDS. The intervention is based upon favorable results in animal and ex-vivo lung models. Pitt has enrolled 9 participants, with Sarah Rapport (PACCM) as lead coordinator with assistance from MACRO. Dr. McVerry also leads a Pitt ARDS registry, the goal of which is to provide clinical data and biospecimens to support translational research in ARDS. The registry currently has over 200 participants and is actively recruiting.

 

ROSE

Lead by Drs. David Huang (PI), Bryan McVerry, Donald Yealy, and Derek Angus, with overall coordination in Pittsburgh/Denver/Harvard, ROSE (Reevaluation Of Systemic Early neuromuscular blockade) is a multicenter Phase III trial to assess the efficacy and safety of early neuromuscular blockade in reducing mortality and morbidity in patients with moderate-severe ARDS. ROSE builds on three French trials which suggested benefit. Pitt has enrolled 11 participants in Presbyterian and Montefiore, with Andrew Jockers as lead coordinator. We will also soon launch ROSE at Mercy (Dr. Chenell Donadee), Shadyside (Dr. Jennifer McComb), and Hershey Medical Center. ROSE is the first trial to be launched by the new NHLBI funded PETAL (Prevention and Early Treatment of Acute Lung injury) Network, the successor to the ARDS Network.

GRAIL

Lead by Dr. Scott Gunn (PI), with overall coordination in Seattle, GRAIL (Ganciclovir/valganciclovir for prevention of cytomegalovirus [CMV] Reactivation in Acute Injury of the Lung and respiratory failure) is a multicenter trial to evaluate the effect of ganciclovir on CMV positive patients who require mechanical ventilation (including ARDS) and sepsis or trauma. Ganciclovir is routinely given to ill transplant patients with elevated CMV; unknown is whether ganciclovir should be given to ill non-transplant patients with elevated CMV. Pitt enrolled their 29th patient on April 29th, with Pam Fazio as lead coordinator. With this enrollment, the study goal was reached and the University of Pittsburgh/MACRO moved in to first place nationwide for enrollment. 

 

Clinical Research "Critical" to Promoting Public Health

During the ACRP 2016 Global Conference & Exhibition on April 16-19, in Atlanta, GA, FDA Commissioner, Robert M. Califf told attendees “now more than ever, the work of clinical researchers is absolutely critical to identifying and vetting potential life-saving drugs and devices.”

For the full story, click here: http://newsmanager.commpartners.com/acrpwire/issues/2016-04-28/index.html

 

Spotlight on High Enrolling ICUs: 6F/G &TICU

MACRO CRCs have been busy enrolling in 6F/G & TICU! In 2016, MACRO CRCs have enrolled 17 subjects in these two ICUs, in six of our research studies. Patients in 6F/G have been enrolled in ATOX Bio (1), ProGReSS (2) and ROSE (3). Patients in TICU have been enrolled in BMS (1), ATHOS3 (1), Plasma (1), ProGReSS (1), and ROSE (7). (See Actively Recruiting Studies for a more detailed description of each study). A big thank you to the 6F/G & TICU staff for the referrals and their hard work helping MACRO increase enrollment!

 

February 2016

Two New Studies Begin Screening 

On June 8, 2015 MACRO began screening for STOP-AKI and enrolled the first subject in August.

This is a randomized, double-blind, placebo-controlled, four-arm, parallel-group, proof of concept, dose-finding, adaptive, phase 2a/2b study to investigate the safety, tolerability and efficacy and effect on quality of life of human recombinant alkaline phosphatase (recAP) in the treatment of patients with sepsis-associated acute kidney injury (SA-AKI).

The primary objectives are:

  • To investigate the effect of recAP on renal function and related clinical parameters in patients with SA-AKI.
  • To determine the therapeutic dose(s) of recAP to support the pivotal Phase 3 program.

Dr. Raghavan Murugan is the Principal Investigator and MACRO’s lead coordinator is Pam Fazio.


On October 1, 2015, MACRO began screening and enrolling for ATHOS3 (Angiotensin II for the Treatment of High-Output Shock).  Since opening, there have been four enrollments.  Dr. Raghavan Murugan is the Principal Investigator and MACRO’s lead coordinator is Andrew Jockers.  

ATHOS3 is a phase 3, placebo-controlled, randomized, double-blind, multicenter study sponsored by La Jolla Pharmaceutical Company, Inc.  The purpose of this study is to test a new drug called LJPC-501 (also known as angiotensin II) in patients with Catecholamine-Resistant Hypotension (CRH).

 

Meet Our Newest Clinical Research Technician - Erin Gilchrist, BS

Erin graduated from the University of Pittsburgh in April 2015, where she majored in Psychology and Sociology. While studying at Pitt, Erin worked as a MACRO Research Associate (RA) for 4 years. In August 2015, she began working full time with MACRO.  Currently, she assists with undergraduate RA intern administration and training as well as trauma study administrative tasks. To date, her greatest accomplishment was being voted best Penguins fan by her colleagues! 

MACRO Research Associate Alumnus Publishes

On August 13th, MACRO Research Associate (RA) alum (2012), Patrick Coppler, first authored a publication in Prehospital Emergency Care on Accuracy of Prehospital Intravenous Fluid Volume Measurement by Emergency Medical Services. Click here to read the full article.

Patrick Coppler began working for MACRO as a RA in August 2012.  After graduating from the University of Pittsburgh in December 2012, where he majored in Music and minored in Neuroscience; Patrick continued working with MACRO as a Graduate Student Researcher on multiple trials at Mercy and Presbyterian.

In September 2014, Patrick began at the University of the Sciences in Philadelphia, PA to obtain his Physician’s Assistant degree.

We hope to collaborate with Patrick as one of our PIs in the near future!

Conference & Educational Activities

Barbara Early

On October 14th, MACRO Clinical Coordinator Director Barbara Early served on a panel discussion at the Model Agreements & Guidelines International (MAGI) Clinical Research Conference in San Diego. The discussion was entitled “Site Operations Challenges: Do You Really Expect Us to Do This? - What happens when a sponsor or CRO makes ‘unreasonable’ demands on a site?”

Dan Unikel

MACRO Financial Manager Dan Unikel was the keynote speaker for the Greater Pittsburgh Chapter of the Association of Clinical Research Professionals (ACRP) Educational Dinner on November 4th. During the dinner, Dan presented his take on financial management with his presentation entitled “Healthy Habits to Keep Clinical Research out of the Financial Emergency Room.” 

 

August 2015

ProACT Expands to UPMC Mercy

On June 11, 2015, MACRO Research Assistants (RA) started to screen and enroll in ProACT (Procalcitonin Antibiotic Consensus Trial). Since opening, there have been nine enrollments.  Drs. Heather Prunty & Brian Suffoletto are spearheading ProACT at Mercy. Megan Buhay will assist as the lead RA with MACRO coordinator, Denise Scholl. 

ProACT is a multi-center, NIH-funded, randomized trial that targets emergency department patients with clinically diagnosed lower respiratory tract infection (LRTI) and test the effects of implementation of a procalcitonin antibiotic guideline for LRTI. The University of Pittsburgh serves as both the Coordinating Center (PI – David Huang) and a site.

Study of Tranexamic Acid during Air Medical Prehospital Transport (STAAMP) Trial

STAAMP is a multi-center, DOD-funded, prospective, randomized, blinded, controlled interventional trial over 3 years focusing on patients with concern for bleeding who are transported via air medical transport to definitive care.

The University of Pittsburgh will serve as both the Coordinating Center and a site. Additional sites include the University of Arizona, University of Texas, San Antonio, and University of Utah.

MACRO opened STAAMP to enrollment on June 11, 2015 and successfully enrolled their first subject on June 13th.  Total enrollment to date is eight. Dr. Jason Sperry and Dr. Frank Guyette are the Principal Investigators and Pete Adams is the study coordinator.

More information on the trial is available at www.staampstudy.com.  

ACRP 2015 Global Conference & Exhibition

Peter Adams and Stacy Stull presented their poster The MACRO Research Assistant Program: A Winning Solution for Acute Care Research and Undergraduate Students at the ACRP 2015 Global Conference & Exhibition in Salt Lake City, UT.

Their work focused on the history, development, and results of the MACRO Research Assistant Program, which employs University of Pittsburgh undergrads as an essential component of our research operations. In 2015, the program was revamped into a formal internship, following advice from the University School of Medicine.

MACRO research assistants screen the UPMC Presbyterian and Mercy Emergency Departments for eligible patients, facilitate enrollment in select studies, interact with multiple acute care providers to ensure protocol execution, and execute many other important tasks. Simultaneously, our research assistants obtain valuable experiential and didactic education; 31 MACRO Research Assistants have gone to medical and other healthcare graduate schools over the last 6 years.

The graph to the right shows where our research assistants have gone post-graduation.

Mad Mex Benefit Dinner

On June 9th, MACRO held a benefit dinner for Pitt undergraduate Research Assistants (RA) at Mad Mex in Shadyside.

Approximately 38 people attended the benefit where Mad Mex donated the space, food and service! All proceeds will go towards our hard-working, largely pre-med, Pitt undergrads who work and learn with MACRO.

Thank you to all that attended and/or contributed to our recent Mad Mex fundraiser!

Click here to view pictures of the dinner.