Public Notification of Completion of the ACCESS Clinical Trial 

A medical research study to which of two standard treatments, if any, results in better outcome: (1) Initial cardiac catheterization laboratory (CCL) admission, or (2) initial intensive care unit (ICU) admission in the emergency department was recently performed in this community. Adults 18-80 years of age successfully resuscitated from out-of-hospital cardiac arrest with no signs of a heart attack on tracings of the heartbeat were enrolled.

The ACCESS trial was stopped early, in July 2019, because the rate of subject enrollment was too low. The study results showed no difference in patient outcomes between treatment with initial CCL admission compared to initial ICU admission, including survival and functionally favorable survival at hospital discharge and 3 months following hospital discharge, but given the low number of subjects enrolled, study data may have proven otherwise had more subjects been enrolled and more data collected.

The researchers thank the community for their support of this research. The study, called ACCESS, was funded by the National Heart, Lung and Blood Institute (NHLBI).

PI - Jessica Smith, MD

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This is the (EFIC) research project post-enrollment public disclosure plan. 

Results of the Established Status Epilepticus Treatment Trial (ESETT).

The ESETT trial was conducted through the NIH-funded Neurological Emergencies Treatment Trials Network, NETT.

RI Hospital and Hasbro Children’s Hospital enrolled 18 patients or 3.76% of the total trial enrollment. The trial compared three medications commonly given to patients with status epilepticus. The three medicines that were studied were levetiracetam (Keppra), fosphenytoin (Cerebryx), and valproate (Depacon).  The research found that all three medicines were similarly effective and similarly safe.  None of the three medicines were better than the others.  Doctors can now confidently use any of these medications to treat patients with status epilepticus.  The results were published in the November 28, 2019 issue of the New England Journal of Medicine.  More details about the research results are available at our website esett.org [esett.org], and will also be posted on the government website clinicaltrials.gov [clinicaltrials.gov] . 

 Principal Investigators are Jessica Smith M.D. and Dale Steele M.D.