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Clinical Trial Summary

The goal of this study is to rapidly cool trauma victims who have suffered cardiac arrest from bleeding with a flush of ice-cold sodium chloride to preserve the patient to enable surgical control of bleeding, followed by delayed resuscitation with cardiopulmonary bypass.


Clinical Trial Description

The intent of the technique to be studied is to induce a state of hypothermic preservation in trauma victims who have exsanguinated to the point of cardiac arrest. In appropriately selected subjects, after an initial emergency attempt at resuscitation with standard techniques, an arterial catheter will be inserted into the descending thoracic aorta. Using appropriate tubing, pump, and heat exchanger,a large quantity of ice-cold saline (0.9% Sodium Chloride for Injection USP) will be pumped as rapidly as possible into the aorta with the goal of cooling the brain (tympanic membrane temperature, Tty) to <10 C. If possible, a large venous catheter will be placed and recirculation of fluid established. Once the subject has been sufficiently cooled, bleeding will be controlled surgically. The subject will then be resuscitated and rewarmed with full cardiopulmonary bypass. The goal is to improve neurologically-intact survival in these patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01042015
Study type Interventional
Source University of Maryland, Baltimore
Contact Samuel A Tisherman, MD
Phone 410-328-9781
Email stisherman@som.umaryland.edu
Status Recruiting
Phase Phase 2
Start date October 2016
Completion date December 2024