Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Penetrating trauma with clinical suspicion of exsanguinating hemorrhage
- •At least 1 sign of life at the scene (pulse, respiratory efforts, spontaneous movements, reactive pupils)
- •Loss of pulse <5 min prior to Emergency Department (ED) arrival or in ED or operating room
- •ED thoracotomy performed without immediate return of a palpable pulse in the carotid arteries after clamping the descending thoracic aorta
排除标准
- •No signs of life for >5 min prior to the decision to initiate EPR
- •Obvious non-survivable injury
- •Suggestion of traumatic brain injury, such as significant facial or cranial distortion
- •Electrical asystole
- •Rapid external assessment of the injuries suggests massive tissue trauma or blunt trauma involving multiple body regions
- •Pregnancy
- •Prisoners
研究组 & 干预措施
Concurrent controls
These subjects would undergo standard resuscitative efforts.
干预措施: Standard resuscitation (Other)
Emergency preservation and resuscitation
These subjects would undergo the complete EPR protocol, including rapid induction of hypothermia, resuscitative surgery, and resuscitation with cardiopulmonary bypass.
干预措施: Emergency preservation and resuscitation (Combination Product)
结局指标
主要结局
The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).
时间窗: Hospital discharge
次要结局
- Multiple organ system dysfunction(During the initial hospitalization)
- Feasibility of initiating EPR (cooling and achieving goal brain temperature)(1 hour)
- Neurologic functional outcome(12 months)
- Survival(28 days)
研究者
Samuel Tisherman
Professor of Surgery
University of Maryland, Baltimore