ADVANCE
SUMMARY:
Utilization of dalbavancin or vancomycin in patients presenting to the ED with soft tissue skin infection. Operational outcome study using drug with FDA approved indication.
CONTRACT:
TGH Acute Research
PI = Wein, TEAMHealth/USF Emergency Medicine, Coordinator = Bader, TGH OCR
OPERATIONAL FLOW:
RA logs patient in RedCap and
calls 813.394.3025
or physician identifies patient via clinical alert in Epic
ENROLLMENTS: 0
STATUS:
Starting in March, All contracts and SIV completed, anticipate drug delivery
SPONSOR:
Portola
SUMMARY:
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant mucocutaneous HSV infection, treated with pritelivir 100 mg qd (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or foscarnet 40 mg/kg iv tid/60mg/kg iv bid.
PI = Alrabaa, USF Infectious Disease, Coordinator = Bader, TGH Acute Care Research Team
CONTRACT:
USF Contract, Run by TGH Acute Care Research
OPERATIONAL FLOW:
RA logs patient in RedCap and
calls 813.394.3025
or physician identifies patient via clinical alert in Epic.
ENROLLMENTS:
0
STATUS:
Enrollment has not started
UPDATES:
SIV on March 5,2018
AKPA
SUMMARY:
Medication for patients in Septic Shock.
PI = Wilson, Coordinator = Ruen
CONTRACT:
USF Contract, Contract assumed by TGH Acute Care Research Team Near end of study enrollment
OPERATIONAL FLOW:
RA logs patient in RedCap and
calls 813.394.3025
or physician identifies patient via clinical alert in Epic.
ENROLLMENTS:
0
STATUS:
Enrollment ended and close out visit completed
UPDATES:
Likely will initiate a second study with company later in 2018.
SUMMARY:
This is an Open label, randomized, active control, parallel-group pilot trial to examine the effect of initiation of APIXABAN at days 0-3 (TIA), days 3-5 (small stroke) and days 7-9 (medium stroke) to decrease fatal and/or recurrent stroke/TIA in 120 subjects who have suffered a recent( 0 to 48 hours from symptoms) TIA, or small to medium ischemic stroke compared to standard of care warfarin treatment regimen. Subjects will be randomly assigned in a 1:1 ratio to one of two treatment arms (apixaban or warfarin). Subjects will be followed for a total of 180 days during from screening through monthly follow-up visits.
TGH SITE PI: Dr. Labovitz, USF Cardiology, SC = Nhi Tran
,
USF Health
CONTRACT:
USF study screened by acute care research team.
OPERATIONAL FLOW:
RA logs patient in RedCap and sends email to Nhi Tran at
nntran@health.usf.edu
regarding possible study subjects.
ENROLLMENTS:
62 Patients enrolled 2015-2018.
STATUS:
Enrolling
SPONSOR:
Pfizer
SUMMARY:
Pediatric Anticoagulation for VTE.
CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for thrombosis
PI = Galligan, SC = Erica Silverman
CONTRACT:
USF Study run by TGH OCR with Screening by TGH Acute Care Research Assistants
OPERATIONAL FLOW:
Research assistants screen patients and enter potential subjects in RedCap log and also end email to
esilverman@tgh.org.
ENROLLMENTS:
0 Enrollments
STATUS:
Enrolling
SPONSOR:
Pfizer
SUMMARY:
This study is designed to evaluate the efficacy and safety of intravenous Lucassin® (terlipressin) versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in subjects receiving standard of care albumin therapy.
PI = Kemmer, Coordinator = Reilly
CONTRACT:
TGH Study run by Acute Care Research Team
OPERATIONAL FLOW:
Research assistants screen patients and enter potential subjects in RedCap log and also end email to Michelle Reilly at
mreilly@tgh.org
Michelle Reilly and Dr. Kemmer also actively screen for this study.
ENROLLMENTS:
Enrollments = 2. Both enrollments in 2017.
STATUS:
Enrolling
SPONSOR
: Ikaria
SUMMARY
Dalteparin sodium (FRAGMIN) in a pediatric population with a diagnosis of Pulmonary Embolism.
PI = Galligan, Coordinator = Silverman.
CONTRACT:
USF Contract, Run By TGH OCR and Screening by TGH Acute Care Research Team.
OPERATIONAL FLOW:
Patients identified by acute care research assistant, logged into redcap and email sent to Erica Silverman at
esilverman@tgh.org
ENROLLMENT:
1 Patient Enrolled
STATUS:
Enrolling
Closed to enrollment on December 31, 2017. No close out scheduled.
SPONSOR:
Pfizer
SUMMARY:
Utilization of rivaroxaban at discharge in hospitalized patients.
PI = Ledford, Coordinator = Tonya, Status = Enrollment Completed.
CONTRACT:
USF Contract run by TGH Acute Care Research Team
OPERATIONAL FLOW:
Tonya Fish reviews Epic report along with assistance from research assistant
ENROLLMENT:
2 Screen Fails in 2017.
STATUS:
Enrollment is closed.
SPONSOR:
Janssen
UPDATES:
Site Visit before lockout planned for 2/23/2018.
SUMMARY:
This study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.
PI =Benbedeis, USF Neurology, Coordinator = Ballans
CONTRACT:
USF Contract run by TGH Acute Care Research Team
OPERATIONAL FLOW: ED research assistants will screen for active status epileptics patients and contact TGH OCR RN?
ENROLLMENT:
0
STATUS:
Enrollment has not started.
SPONSOR:
Marinus Pharma
UPDATES:
Site Visit completed in February 2018
SUMMARY:
The goal of
SOAR
is to characterize the clinical and economic impact of clinicians' responses to major bleeding complications and pre-procedural concerns for bleeding risk in patients treated with oral anticoagulants (warfarin, anti-Xa orals, and anti-thrombin (IIa) orals) who present to the ED or in the hospital with acute illness or injury, with the eventual aim of informing the development of improved approaches to the management of OACs in the ED.
PI = Wilson, Coordinator = Pierre. Status = Ongoing.
CONTRACT:
TGH Contract, Run by TGH Acute Care Research Team
OPERATIONAL FLOW:
Research assistants screen by LEX-209 BPA, Annexa BPA, Bleed Report, and RE-COVERY report. Log
Patient into Redcap and send email to Louis Pierre at
lpierre@tgh.org
ENROLLMENT:
Enrolled 63 since study initiation. 17 in 2018. 31 on Warfarin and 4 on Dabigatran. 28 on Factor Xa (9 Apixaban, 19 Rivaroxaban).
STATUS:
Enrolling
SPONSOR:
Hospital Quality Foundation.
UPDATES:
Fulfilled enrollment for Warfarin. Can only enroll dabigatran from this point forward.
SUMMARY:
A phase one study to characterize the pharmacokinetics of
dalbavancin
in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of
dalbavancin
.
PI = Patterson, TEAMHealth/USF Emergency Medicine, Coordinator = Fish, TGH Acute Care Research Team
CONTRACT:
TGH Contract, Run by TGH Acute Care Research Team
OPERATIONAL FLOW:
RA logs patient in RedCap and
calls 813.394.3025
or physician identifies patient via clinical alert in Epic.
ENROLLMENT:
0
STATUS:
Enrolling
SPONSOR:
Durata/Allergan
SUMMARY:
Utilization of dual anti platelets in patients with an NSTEMI requiring cardiac catheterization within 72 hours.
PI = Wilson, TEAMHealth/USF Emergency Medicine, Coordinator = Pierre, TGH Acute Care Research Team
CONTRACT:
TGH Contract, Run by TGH Acute Care Research Team
OPERATIONAL FLOW:
Patients identified by Research Assistants and Louis Pierre using Epic Reports for cardiac catheterization and utilization of ticegralor or clopidogrel after NSTEMI
ENROLLMENT:
52 patients, 0 in 2018
STATUS:
Enrolling
SPONSOR:
Hospital Quality Foundation.
UPDATES:
Louis Pierre met with Dr. Matar in February 2018 who asked about sponsors, budget and asked for protocol. He is open to discussion regarding. Louis will follow up with Dr. Matar. Louis Pierre also met with Dr. Berlowitz who is supportive of study goals. Dr. Berlowitz concerns center around respiratory issues and other side effects in older patient population with comorbidities. We will try to evaluate the patient for comorobidities and assess for younger, healthier patients. Louis and Ashley will drill down on ordering providers in ED and help create a selection criteria for appropriate ticegralor patient.
VERTEX
SUMMARY:
Treatment of patients with cervical spine injury and C4 or lower neurological deficit.
PI = Vale, USF Neurosurgery, Coordinator = Ballans, TGH Acute Care Research Team
CONTRACT:
USF Contract, Run by TGH Acute Care Research Team
OPERATIONAL FLOW: Neurosurgery/EM Physicians/Research Assistants/Research Nurses screen appropriate patients acutely during normal clinical flow, usually in trauma bay.
ENROLLMENT:
3, 1 in Februar 2018
STATUS:
Enrolling
SPONSOR:
UPDATES:
Heather Henderson
identified patient in Trauma Bay during screening shift after MVC and Louis Pierre was on and enrolled patient with help of Neurosurgery. Tonya Fish RN came in and took over RN.
VU-ESSENCE
SUMMARY:
Genetic profile of patients with ischemic stroke.
PI = Burgin, USF Neurology, Coordinator = Bozeman, USF Health. TGH Liaison Coordinator = Ballans, TGH Acute Care Research Team
CONTRACT:
USF Contract, Some operations by RN coordinator, screening by TGH Acute Care Research Assistants
OPERATIONAL FLOW:
Research Assistants respond to stroke alerts in ED
ENROLLMENT: 43, 12 enrolled in January 2018, 1 enrolled in February 2018
STATUS:
Enrolling
SPONSOR:
UPDATES:
Approaching IRB to increase to 100 patients. Research Assistant Epic notes being corrected and checklist being created by Brandi.
