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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
166
Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors
Normal saline solution
Oregon Health & Science University
Portland, Oregon, United States
Feasibility of study drug administration
Number of study drug kits opened and given to patients prior to hospital arrival.
Time frame: First 24 hours after injury
Mortality
To evaluate mortality at 3 hour, 24 hour, and 30 days
Time frame: First 30 days after injury
Hospital Free Days
Number of days out of the hospital
Time frame: First 30 days after injury
ICU Free Days
Number of days out of the ICU
Time frame: First 30 days after injury
Ventilator Free Days
Number of days not on a ventilator
Time frame: First 30 days after injury
Blood Transfusions
The amount of blood products transfused in the first 24 hours
Time frame: First 24 hours after injury
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