Prehospital Kcentra for Hemorrhagic Shock
- Conditions
- Trauma Injury
- Interventions
- Drug: Placebo
- Registration Number
- NCT04019015
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 166
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo A single infusion of volume matched placebo solution (Normal Saline) Kcentra Prothrombin Complex Concentrate, Human 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
- Primary Outcome Measures
Name Time Method Feasibility of study drug administration First 24 hours after injury Number of study drug kits opened and given to patients prior to hospital arrival.
- Secondary Outcome Measures
Name Time Method Mortality First 30 days after injury To evaluate mortality at 3 hour, 24 hour, and 30 days
Hospital Free Days First 30 days after injury Number of days out of the hospital
ICU Free Days First 30 days after injury Number of days out of the ICU
Ventilator Free Days First 30 days after injury Number of days not on a ventilator
Blood Transfusions First 24 hours after injury The amount of blood products transfused in the first 24 hours
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States