Emergency Medicine

Resuscitation Outcomes Consortium (ROC)

The Resuscitation Outcomes Consortium (ROC) was created to learn which treatments work when people have a cardiac arrest or severe injury. The ROC consists of ten sites and a coordinating center. The ROC investigators work with Emergency Medical Services (EMS) systems and local hospitals at each site to do these studies. Treatments studied include promising resuscitation drugs, tools and techniques.

The ROC Investigators do studies in which people who qualify receive either the currently accepted treatment or a new treatment assigned by chance (that is, in a manner like a coin toss). The trials are designed to test promising new treatments so that EMS providers can use those treatments most likely to benefit the public.

The ROC network finished its last study in 2019.  This network was funded by a series of cooperative agreements with 10 regional clinical centers and one data coordinating center from the National Heart, Lung, and Blood Institute in partnership with the National Institute of Neurological Disorders and Stroke, U.S. Army Medical Research and Materiel Command, the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research, Defence Research and Development Canada, the Heart and Stroke Foundation of Canada, and the American Heart Association.

This study involved ambulance patients and was in two parts - Study 1 was to see how a small amount of an IV fluid that had a higher concentration of salt than normal may help patients who have lost a significant amount of blood due to gunshot, stabbing, or blunt trauma injuries. Study 2 also involved the higher salt concentration IV fluid, but the patients involved were blunt trauma patients with a severe traumatic brain injury. Both studies were randomized trials comparing hypertonic saline and a sugar (called dextran) mix, hypertonic saline alone, and normal saline as the initial resuscitation fluid administered to these patients in the prehospital setting. Neither the paramedics administering the IV fluid nor the patient knew which fluid he or she was receiving.

October 11, 2010
Results published in JAMA.
View the article and results here

May 12, 2009
Hypertonic Saline in Traumatic Brain Injury study stopped
For more information about the closure of the study see the NIH press release or www.clinicaltrials.gov
For more information about traumatic brain injury, visit the website: National Institute of Neurological Disorders and Stroke - Traumatic Brain Injury: Hope Through Research

March 26, 2009
Hypertonic Saline in Trauma Patients in Shock-stopped
For more information about the closure of the HS shock study see the NIH press release   or visit www.clinicaltrials.gov

Prehospital Resuscitation using an Impedance valve and Early vs Delayed analysis (PRIMED)

Cardiac arrest is the sudden, abrupt loss of heart function. Death usually occurs within minutes unless cardiopulmonary resuscitation (CPR), rapid defibrillation, and paramedic interventions are available. CPR consists of pumping on the patient's chest and delivering breaths to produce some circulation until the heart can be restarted. When the chest is compressed, oxygen-rich blood is pumped forward. When the chest is released, oxygen-poor blood is brought back to the heart and lungs where it can be restored with oxygen before being pushed out to the body with another compression. Both actions -- pushing oxygen-rich blood forward and bringing oxygen-poor blood back to the heart and lungs -- are important. CPR however produces only about 30% of normal circulation. Methods to improve the circulation produced by CPR may lead to better survival.

This study was completed on November 6, 2009
For more information about the completion of the study,
please read the official OHSU press release and the NIH press release here     

Publications

Results were published in the New England Journal of Medicine on September 1, 2011.

Cardiac Arrest and the Limitations of Clinical Trials
Read the Editorial

A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest
Read the Article

Early versus Later Rhythm Analysis in Patients with Out-of-Hospital Cardiac Arrest
Read the Article

Field Trial of Hypotensive Resuscitation versus Standard Resuscitation in Patients with Hemorrhagic Shock after Trauma, A Pilot

Trauma is the leading cause of death for people between the ages of 1 and 44 years. Approximately 80% of trauma patients who die do so from severe brain injury, severe bleeding or a combination of the two. Over 50% of trauma deaths occur in the first 12 hours after injury and the most common cause of unnecessary death after trauma is severe bleeding.

If the amount of blood lost is too large, vital organs such as the brain, heart, lungs, and kidneys will not receive the blood they need to function properly. To help support the blood flowing to these vital organs, a special fluid called normal saline (0.9% sodium chloride injection) is routinely given through a tube into a blood vessel. Paramedics give normal saline to an injured person while the person is being safely removed from the scene and taken to the nearest hospital.

The purpose of this study is to determine if severely injured people do better when they are given small amounts of normal saline or if they do better when they are given large amounts of normal saline. Currently, giving large amounts of normal saline is the normal treatment.

This study enrolled subjects across the United States and Canada. The study enrolled people here in the Portland/Vancouver area. Half received the traditional large amounts of fluid, and half received the experimental small amounts of fluid.

Enrollment Closed on April 29th, 2013
For more information about the closure of the study, please read the official OHSU press release.   

The National Institutes of Health has more details on each of the ROC studies: HypoResus (NCT01411852)

Amiodarone, Lidocaine, Placebo Study (ALPS)

There are approximately half a million cardiac arrests that occur in the United States each year. Nearly two-thirds, or about 350,000, cardiac arrests occur outside the hospital. Nationally, only about 5% of cardiac arrest victims survive. Cardiac arrest occurs when the heart stops beating. When the heart stops beating, blood-containing oxygen does not get to vital organs, such as the brain, lungs, kidneys, and the heart itself. When oxygen is not available, organs may be permanently damaged or the patient may die. Life-supporting interventions must be given immediately in the field to save their life. Standard care for cardiac arrest includes providing chest compressions, breathing assistance and the use of heart rhythm medications (Amiodarone and/or Lidocaine) in some instances. Even with these treatments, only 10-15% of patients survive cardiac arrest with good brain function in our local community. This study is being done to figure out the best method of treating those who suffer from cardiac arrest outside of the hospital, in order to ensure the highest rate of survival.

For more information about the study, read the official ALPS NIH Press release   or the ALPS OHSU Press release. 

Enrollment Closed on October 24th, 2015

Results were published in the New England Journal of Medicine on April 4, 2016. Read the publication

Tranexamic Acid for Traumatic Brain Injury

Oregon Health & Science University is part of a multi-site study testing whether people who have life-threatening or life-altering traumatic brain injury do better when they receive a medication called Tranexamic Acid (TXA) that is used to stabilize bleeding in the body. The study will be conducted at 10 Level 1 trauma centers in North America, including OHSU. The research team will look at the results to determine if the study medication, TXA, given as soon as possible after injury, improves the mental recovery after traumatic brain injury.

2017 -TXA closed enrollments.

Pragmatic Airway Resuscitation Trial

Oregon Health & Science University is part of a multi-site NIH funded prehospital study designed to determine if either of two airway management strategies currently used in the management of out-of-hospital cardiac arrest is better than the other. Cardiac arrest is defined as a severe malfunction or cessation of the electrical and mechanical activity of the heart. The heart essentially stops beating, blood does not circulate and a pulse cannot be felt. Cardiac arrest results in almost instantaneous loss of consciousness and collapse.

Enrollment began on March 29th, 2016 and was completed in 2018. 

Learn about the results: Journal of Emergency Medical Services article