Status:
UNKNOWN
Prehospital Kcentra for Hemorrhagic Shock
Lead Sponsor:
Oregon Health and Science University
Conditions:
Trauma Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04019015
Start Date
March 15 2021
End Date
March 31 2025
Last Update
December 15 2023
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239