The goal of the SIREN Network is to improve the outcomes of patients with neurologic, cardiac, respiratory and hematologic emergencies by identifying effective treatments given in the earliest stages of care. SIREN is a cooperative and highly integrated clinical trials network that will build upon guiding design principles and organizational values essential for success. These include focus on:

• early treatment
• meaningful outcomes for patients
• efficiency
• collaboration
• transforming the clinical trials enterprise

Studies

Please read our newsletter (above) for the latest updates on trials such as network and site-specific enrollment totals. 

HOBIT - Hyperbaric Oxygen Brain Injury Treatment Trial

• Registered with ClinicalTrials.gov: NCT02407028
• NIH Project Number: 1U01NS095926-01A1

The OHSU Network has 2 institutions participating in HOBIT.  Duke University Medical Center and Ohio State University Wexner Medical Center are currently enrolling subjects. This study began enrollment in August 2018. 

BOOST-3 - Brain Oxygen Optimization in Severe TBI Phase-3

• Registered with ClinicalTrials.gov: NCT03754114
• NIH Project Number: 1U01NS099046-01A1 

The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other.

This study began enrolling in Sept 2019.  OHSU Partner site University of Rochester Medical Center - Strong Memorial Hospital is currently enrolling subjects.  OHSU began enrollment locally on March 16, 2020.  Duke University Medical Center, Ohio State University Wexner Medical Center, and University of Utah will all be participating in this trial and are expected to begin enrollment in 2020. 

BioBOOST - The main goal of Bio-BOOST is to determine how the lack of oxygen to brain tissues affects the levels of blood tests for brain injury.  OHSU is 1 of 10 sites that will be participating in the sub-study of BOOST3.

ICECAP - Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients 

• Registered with ClinicalTrials.gov: NCT04217551 
• NIH Project Number: 1UG3HL145269-01A1 

The Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP) study will enroll comatose adult survivors of out of hospital cardiac arrest that have already been rapidly cooled using a definitive temperature control method. Those with and without initial shockable rhythms will be studied as distinct populations (maximum of 1800 subjects over four years). ICECAP will determine if identifying an optimal duration of cooling can improve outcomes, and if development of a duration response curve can substantiate efficacy in a wider patient population.

This study has been funded and is in the pre-trial preparation phase.  It is anticipated that enrollment will begin in 2020. OHSU Network partners that are expected to enroll in ICECAP are: OHSU - Adventist, Ohio State University Wexner Medical Center, University of Alabama -Birmingham, University of Rochester Medical Center - Strong Memorial Hospital, University of Utah, and potentially Duke University Medical Center and Wake Forest Baptist Health.  

C3PO - Clinical Trial of COVID-19 Convalescent Plasma of Outpatients

The Clinical Trial of COVID-19 Convalescent Plasma in Outpatients (C3PO) is a multi-center randomized, single blind, two arm, placebo controlled phase III trial with blinded outcome assessment to establish the safety and efficacy of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. 

COVID-19 is a respiratory illness caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). 

The overarching goal of this trial is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization. 

This study began at OHSU on 8/19/20.  The OHSU network has 4 additional partner sites who enrolled in C3PO - OSU, URMC, Utah and Duke.