What is ROC?
The Resuscitation Outcomes Consortium (ROC) was created to conduct clinical research in the areas of cardiopulmonary resuscitation and traumatic injury. ROC consists of 10 Regional Clinical Centers (RCCs) and a Data and Coordinating Center (DCC) that will provide the necessary infrastructure to conduct multiple collaborative trials to aid rapid translation of promising scientific and clinical advances to improve resuscitation outcomes. Trials may evaluate existing or new therapies (such as pharmacologic immune modulators) as well as clinical management strategies (such as new resuscitative fluids, novel hemorrhage control strategies, the use of cerebral protection and neurologic preservation, metabolically directed therapies, and alternative methods of delivering CPR or defibrillation). ROC Website
Who are the Sponsors?
- The National Heart, Lung and Blood Institute
- The U.S. Department of Defense
- Other Institutes within the National Institutes of Health
- The Institute of Circulatory and Respiratory Health (ICRH) from the Canadian Institutes of Health Research
- Canadian Defense Research and Development
Who will conduct the research?
- The ROC consists of the following EMS systems in the cities or regions:
- Alabama Resuscitation Center: Tom Terndrup, MD, Principal Investigator
- Dallas, TX: Ahamed Idris, MD, Principal Investigator
- Iowa City, IA: Richard Kerber, MD, Principal Investigator
- Milwaukee, WI: Tom Aufderheide, MD, Principal Investigator
- Pittsburgh, PA: Clif Callaway, MD, Principal Investigator
- Portland, OR: Jerris Hedges, MD, Principal Investigator
- Ottawa, Ontario/Vancouver, BC : Ian Stiell, MD, Principal Investigator
- San Diego, CA: Daniel Davis, MD, Principal Investigator
- Seattle/King County, WA: Peter Kudenchuk, MD, Principal Investigator
- Toronto, Ontario: Art Slutsky, MD, Principal Investigator
San Diego ROC Sites Investigators include:
- Daniel Davis, MD, Principal Investigator
- Gary Vilke, MD, Co-Investigator
- James Dunford, MD, Co-Investigator
- Raul Coimbra, MD, Co-Investigator
- Donna Kelly Aker RN, Site Coordinator
- Lana McCallum-Brown RN, Coordinator
- Thea Barsalou EMT-P, RN, Coordinator
- Frank Sutil EMT-P, Field Specialist
Update on Clinical Trials being conducted as of Fall 2009
Hypertonic Saline trial is a randomized, blinded trial comparing: Hypertonic saline (7.5% saline) to Hypertonic saline/Dextran to the current standard of care, Normal saline (0.9% saline) as the initial prehospital resuscitation fluid. The trial has completed the enrollment phase as of April 2009. San Diego contributed 200 of the 3680 participants enrolled across all the sites. It was suspended as the interim analysis did not show that it was better than standard of care at the 28 day survival. There were no issues related to the safety of its use. San Diego was a strong contributor with a very good data entry record. This is still the largest trial of its kind ever done. Analysis of the data will not begin until the last of the 6 month follow up interviews are completed which will not be until after November 2009. We expect more trauma trials to come in the future.
PRIMED Trial is a randomized trial to determine outcomes in cardiac arrest when comparing the difference between analyze early (after 30 seconds of CPR) and analyze later (after 3 minutes of CPR)protocols as well as comparing the difference between CPR with the Impedance Threshold Device (ITD) and CPR with a sham valve. Enrollment is ongoing in the City of San Diego with about 15 patients a week. They are using the ITD device and the Early vs. Late analysis to determine the need for defibrillation. The agencies participating in the County are San Marcos, El Cajon, North County, Julian, Viejas and Poway.
Epistry Trial is our third ROC trial and is ongoing. This is the registry trial for all out-of-hospital cardiac arrests and is our longest running trial. It was used as the base for the types of enrollments we should expect for PRIMED trial. Currently the data that goes to the Epistry trial is the data related to a CPR but is outside of the inclusion criteria such as a child in CPR or a non ROC provider arriving first to the scene. This trial will stay open for several years to come.