Prehospital Kcentra for Hemorrhagic Shock

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Prehospital Trial Comparing Kcentra Plus Standard of Care to Standard of Care Alone in Trauma Patient With Hemorrhagic Shock

Conditions
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Trauma Injury

Intervention / Treatment
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* Drug: Prothrombin Complex Concentrate, Human
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kcentra<br>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 | Drug: Prothrombin Complex Concentrate, Human<br>* Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors<br>* Other names: Kcentra;|
| Placebo Comparator: Placebo<br>A single infusion of volume matched placebo solution (Normal Saline) | Drug: Placebo<br>* Normal saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of study drug administration | Number of study drug kits opened and given to patients prior to hospital arrival. | First 24 hours after injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | To evaluate mortality at 3 hour, 24 hour, and 30 days | First 30 days after injury | 
| Hospital Free Days | Number of days out of the hospital | First 30 days after injury | 
| ICU Free Days | Number of days out of the ICU | First 30 days after injury | 
| Ventilator Free Days | Number of days not on a ventilator | First 30 days after injury | 
| Blood Transfusions | The amount of blood products transfused in the first 24 hours | First 24 hours after injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock, Hemorrhagic, Trauma, Mortality, Wounds and Injuries, Hemorrhage