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Current Studies

ALPS

CCC vs 30:2


Epistry

The primary goal of the Epistry Database working group is to develop the rationale and methods for a standard reliable and valid Epidemiologic databank of out of hospital cardiac arrest and life threatening trauma cases with in-hospital outcomes after 5 years enabling the identification of best practices via observational study and mega trials with the ultimate goal of improving resuscitation success defined as survival to hospital discharge rates across ROC centers.

ROC PROPHET

(Prospective Observational Prehospital and Hospital Registry for Trauma) The primary aims of the PROPHET study are to
1. maintain a comprehensive ongoing data infrastructure to facilitate the design, implementation and interpretation of ROC trauma trials;
2. evaluate the ability of prehospital factors to predict in-hospital measures of injury severity in trauma patients with life threatening injury and
3. evaluate the relationships between prehospital injury characteristics, patient characteristics, EMS and regional structure, processes of care, and outcome in trauma patients with life threatening injury.


Completed Studies

Hypertonic Saline
Hypertonic Saline in Traumatic Brain Injury-completed May 12, 2009

A multicenter trial of hypertonic resuscitation in trauma patients with severe traumatic brain injury (TBI) was stopped May 12, 2009.  The TBI study sought to determine the impact of hypertonic resuscitation on long term (6 month) neurologic outcome and survival.  The study was stopped because it was determined that the hypertonic saline solutions were no better than the standard treatment of normal saline and that it was unlikely that continuing to enroll new patients would change the outcome of the study. There were no concerns about safety. For more information about the closure of the study see the NHLBI press release here or go to 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.

Hypertonic Saline in Trauma Patients in Shock-completed February, 2009

A parallel study using the same intervention for blunt or penetrating trauma patients in hypovolemic shock (patients exhibiting low blood pressure) was stopped in February 2009. The shock study sought to determine the impact of hypertonic resuscitation on survival in trauma patients in hypovolemic shock. The trial was stopped because patients who received the concentrated saline solutions were no more likely to survive than those who received a normal saline solution and had earlier, although not increased mortality. For more information about the closure of the HS shock study see the NHLBI press release here or visit clinicaltrials.gov.

ROC PRIMED-completed November 6, 2009

(Prehospital Resuscitation using an IMpedance valve and Early vs Delayed analysis)
ROC PRIMED, a multicenter trial of patients who suffer a cardiac arrest, when the heart abruptly stops outside of the hospital setting, stopped enrollment on November 6, 2009 . The trial compared two resuscitation strategies delivered by emergency medical service (EMS) providers to increase blood flow during cardiac arrest.  The study's independent monitoring board and the National Heart, Lung, and Blood Institute (NHLBI), the lead sponsor of the study, stopped enrollment based on preliminary data suggesting that neither strategy significantly improved survival. One strategy compared different durations of manual cardiopulmonary resuscitation (CPR) by EMS providers before they assessed whether defibrillation was needed, and the other strategy tested the potential benefits and risks of an investigational device to maintain pressure in the chest during CPR. For more information about the closure of the ROC PRIMED study see the NHLBI press release here or download the ROC PRIMED Questions and Answers.

CPR Feedback-completed November 20, 2009

A multicenter randomized trial to assess whether automated real-time audio-feedback during out-of-hospital cardiopulmonary resuscitation (CPR) would increase return of spontaneous circulation (ROSC) compared to standard CPR alone. Enrollment of 1,521 treated non-traumatic cardiac arrest patients was completed on March 9, 2009. The study was conducted in 21 emergency medical service (EMS) agencies at three ROC regions in the U.S. and Canada. Initial results of the trial were highlighted during the Resuscitation Science Symposium (ReSS) 2009 program. While improved compliance with American Heart Association (AHA) recommendations for CPR performance (time spent doing CPR, rate of compressions, and depth of compressions) improved modestly when feedback was ‘on’, there was no significant difference in ROSC or survival to hospital discharge between the two study groups. Researchers will further analyze and publish the final data in the coming months. For more information about the completion of the CPR Feedback study see the ROC press release here or visit clinicaltrials.gov.

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