Introduction
The Resuscitation Outcomes Consortium was established in 2004 by the National Heart Lung and Blood Institute of the National Institute of Health, in partnership with the Institute of Circulatory Respiratory Health of the Canadian Institutes of Health Research and other agencies. The goal of the ROC is to conduct clinical research in the areas of cardiopulmonary arrest and life-threatening traumatic injury. The ROC has the necessary infrastructure to conduct multiple randomized trials to aid rapid translation of promising scientific and clinical advances to improve resuscitation outcomes. The focus on prehospital interventions recognizes the common epidemiology and physiology of cardiac arrest and trauma, as well as the time-dependent nature of treatment of these disorders.

Clinical trials will evaluate existing or new therapies (such as drug interventions, and strategies of fluid resuscitation), clinical management strategies (such as bleeding control strategies, the use of cerebral protection, metabolically-directed therapies, and alternative CPR approaches), or a combination of the two. Consortium investigators will conduct trials of variable size and duration equally directed towards the cardiac and trauma populations. Baseline data submitted by the participating ROC sites demonstrate large and potentially important variations in the incidence and outcome of cardiac arrest and major trauma as well as EMS practices used to treat them. Failure to control for factors that account for some of these differences will increase the sample size of, and may bias or confound the results of ROC intervention trials. However, the necessity of a ROC Registry has only become apparent since the sites and coordinating center for this trials network were selected, and began to work out the details for proposed intervention trials. It has become clear that the effort required to set in motion the infrastructure for conducting and collecting EMS data is far more complex than that of other clinical trials and once in place is far more efficient to continue between protocols. At present no ROC EMS agency has the infrastructure in place to capture all out-of-hospital cardiac arrest and major trauma episodes. Therefore a registry is necessary to establish a streamlined and persistent method of episode notification to reduce the potential for bias in ROC intervention trials.

Specific Aims of the Database

1. To establish a comprehensive ongoing data infrastructure to facilitate the design, implementation and interpretation of ROC trials.
2. To define the incidence and outcome of out-of-hospital cardiac arrest and life-threatening traumatic injury.
3. To describe the relationships between resuscitation performance and EMS structure, adjusting for episode-specific factors.
4. To evaluate the relationships between outcome and patient, EMS, regional, and periodic factors.

Study Design
This study is a chart review of cardiac arrest and qualifying major trauma patients.

Sudden Cardiac Arrest Inclusion Criteria:
Included will be all individuals who experience cardiac arrest outside the hospital, are evaluated by organized EMS personnel and: a) receive attempts at external defibrillation (by lay responders or emergency personnel), or receive chest compressions by organized EMS personnel; or b) are pulseless but do not receive attempts to defibrillate or CPR by EMS personnel. This group will include patients with do not attempt resuscitation directive signed and dated by a physician, extensive history of terminal illness or intractable disease, or request from the patient's family.

Trauma Inclusion Criteria:
Included will be individuals of any age who experience injury outside hospital who are evaluated by organized EMS personnel and have any of: a) died in the field, b) intubation in the field, c) abnormal vital signs defined as:

• Systolic blood pressure ≤ 90 mmHg
• Respiratory rate < 10 > 29
• Glasgow Coma Scale Score ≤ 12.

There will be no age-based eligibility criteria because: a) serious injury in infants or children is a particularly devastating public health problem with many potential life-years lost, b) cardiac arrest has devastating consequences in children even though it is less common than in adults, c) pediatric injury and cardiac arrest have been greatly under researched, d) children incurring serious injuries or cardiac arrest may be more amenable to new therapies than adults, and e) there is minimal risk associated with the study.

• ROC Epistry Protocol
• Published EPISTRY Papers
  • A Descriptive Analysis of Emergency Medical Services Systems Participating in the Resuscitation Outcomes Consortium (ROC) Network, Davis et al. Prehosp Emerg Care, 2007 Oct-Dec;11(4):369-8.

OHRI members:

Cathy Clement
Jane Banek
Christine Tym
Ghislaine Lepage
Stan Morrow