Prehospital Kcentra for Hemorrhagic Shock

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Protein C; Protein S; Thrombin

Criteria

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