NCT04019015

Prehospital Kcentra for Hemorrhagic Shock

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma Injury

Interventions

Type	Name	Description
DRUG	Prothrombin Complex Concentrate, Human	Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors
DRUG	Placebo	Normal saline solution

Timeline

• Start date: 2021-03-15
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2019-07-15
• Last updated: 2023-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study