Trauma Injury
Conditions
Keywords
Shock, Hemorrhagic, Trauma, Mortality, Wounds and Injuries, Hemorrhage
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.
Interventions
Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors
DRUGPlacebo
Normal saline solution
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Trauma patients age 18 years or greater, or weight \> 50 kg if age unknown 2. Systolic blood pressure \< 70 mmHg 3. Suspicion of hemorrhagic shock based on mechanism of injury 4. EMS transport to a participating trauma center
Exclusion criteria
1. Age less than 18 2. Unknown time of injury 3. Out-of-hospital cardiopulmonary resuscitation 4. Known history of thromboembolic disorders or stroke or suspicion by EMS of a recent stroke 5. Known oral anti-coagulant use to include warfarin and novel anti-coagulants 6. Severe hypothermia (\<28°C) 7. Drowning or asphyxia due to hanging 8. Burns more than 20% total body surface area 9. Evidence of devastating blunt traumatic brain injury to include fixed and dilated pupils, asymmetric pupils and extrusion of brain matter 10. Isolated blunt or penetrating head injury 11. Isolated spinal cord injury 12. Ground level (same level) falls 13. Inability to obtain intravenous access 14. Inability to administer randomized therapy within 4 hours of ambulance notification 15. Known transfers and inter-facility transfers 16. Known Do Not Resuscitate (DNR) prior to randomization 17. Known or suspected pregnancy 18. Known prisoners 19. Patients who have activated the opt-out process
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed