Prehospital Kcentra for Hemorrhagic Shock

Trauma Injury Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Shock, Hemorrhagic
• Trauma Injury
• Wounds and Injuries

• NCT number: NCT04019015
• Study type: Interventional
• Source: Oregon Health and Science University
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 15, 2021
• Completion date: March 31, 2025