A Prospective Randomized Prehospital Trial Comparing Kcentra Plus Standard of Care to Standard of Care Alone in Trauma Patient With Hemorrhagic Shock
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Feasibility of study drug administration
研究概览
简要总结
This is a pilot trial being performed to evaluate the feasibility, to include the ability of EMS to identify patients in shock and the ability to package, store, and administer Kcentra in the field.
详细描述
Prospective randomized trials have shown that 4-factor prothrombin complex concentrate (4FPCCs) result in more rapid correction of coagulopathy and greater likelihood of achieving hemostasis in patients receiving vitamin K antagonists who require emergent operations or who are bleeding. 4FPCCs have not been studied in the pre-hospital setting as a primary resuscitative adjunct. The investigators believe the effects of Kcentra to prevent or treat coagulopathy early after injury combined with its ability to treat the endotheliopathy of trauma and prevent organ failure will results in improved outcomes in severely injured trauma patients with hemorrhagic shock. The investigators have chosen to study a population of trauma patients in severe hemorrhagic shock (SBP < 70mmHg) because this population is at greatest risk for developing acute coagulopathy of trauma and has the greatest potential to benefit from the proposed therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma patients age 18 years or greater, or weight > 50 kg if age unknown
- •Systolic blood pressure < 70 mmHg
- •Suspicion of hemorrhagic shock based on mechanism of injury
- •EMS transport to a participating trauma center
排除标准
- •Age less than 18
- •Unknown time of injury
- •Out-of-hospital cardiopulmonary resuscitation
- •Known history of thromboembolic disorders or stroke or suspicion by EMS of a recent stroke
- •Known oral anti-coagulant use to include warfarin and novel anti-coagulants
- •Severe hypothermia (<28°C)
- •Drowning or asphyxia due to hanging
- •Burns more than 20% total body surface area
- •Evidence of devastating blunt traumatic brain injury to include fixed and dilated pupils, asymmetric pupils and extrusion of brain matter
- •Isolated blunt or penetrating head injury
- •Isolated spinal cord injury
- •Ground level (same level) falls
- •Inability to obtain intravenous access
- •Inability to administer randomized therapy within 4 hours of ambulance notification
- •Known transfers and inter-facility transfers
- •Known Do Not Resuscitate (DNR) prior to randomization
- •Known or suspected pregnancy
- •Known prisoners
- •Patients who have activated the "opt-out" process
研究组 & 干预措施
Kcentra
A single dose of Kcentra based on estimated body weight
- 2000 U for patients with an estimated body weight ≤ 75kg
- 3000 U for patients with an estimated body weight > 75kg
干预措施: Prothrombin Complex Concentrate, Human (Drug)
Placebo
A single infusion of volume matched placebo solution (Normal Saline)
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility of study drug administration
时间窗: First 24 hours after injury
Number of study drug kits opened and given to patients prior to hospital arrival.
次要结局
- Mortality(First 30 days after injury)
- Hospital Free Days(First 30 days after injury)
- ICU Free Days(First 30 days after injury)
- Ventilator Free Days(First 30 days after injury)
- Blood Transfusions(First 24 hours after injury)
研究者
Martin A Schreiber, MD
Professor and Chief of Trauma
Oregon Health and Science University