Development of the emergency preservation and resuscitation for cardiac arrest from trauma clinical trial

BACKGROUND: Patients who suffer a cardiac arrest from trauma rarely survive, even with aggressive resuscitation attempts, including an emergency department thoracotomy. Emergency Preservation and Resuscitation (EPR) was developed to utilize hypothermia to buy time to obtain hemostasis before irreversible organ damage occurs. Large animal studies have demonstrated that cooling to tympanic membrane temperature 10°C during exsanguination cardiac arrest can allow up to 2 hours of circulatory arrest and repair of simulated injuries with normal neurologic recovery. STUDY DESIGN: The Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma trial has been developed to test the feasibility and safety of initiating EPR. Select surgeons will be trained in the EPR technique. If a trained surgeon is available, the subject will undergo EPR. If not, the subject will be followed as a control subject. For this feasibility study, 10 EPR and 10 control subjects will be enrolled. STUDY PARTICIPANTS: Study participants will be those with penetrating trauma who remain pulseless despite an emergency department thoracotomy. INTERVENTIONS: Emergency Preservation and Resuscitation will be initiated via an intra-aortic flush of a large volume of ice-cold saline solution. Following surgical hemostasis, delayed resuscitation will be accomplished with cardiopulmonary bypass. OUTCOME MEASURES: The primary outcome will be survival to hospital discharge without significant neurologic deficits. Secondary outcomes include long-term survival and functional outcome. IMPLICATIONS: Once data from these 20 subjects are reviewed, revisions to the inclusion criteria and/or the EPR technique may then be tested in a second set of EPR and control subjects.