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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Trauma Injury
• Intervention / Treatment: Drug: Placebo; Drug: Prothrombin Complex Concentrate, Human

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.

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kcentra; A single dose of Kcentra based on estimated body weight; 2000 U for patients with an estimated body weight ≤ 75kg; 3000 U for patients with an estimated body weight > 75kg	Drug: Prothrombin Complex Concentrate, Human; Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors; Other Names: Kcentra
Placebo Comparator: Placebo; A single infusion of volume matched placebo solution (Normal Saline)	Drug: Placebo; Normal saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study drug administration	Number of study drug kits opened and given to patients prior to hospital arrival.	First 24 hours after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	To evaluate mortality at 3 hour, 24 hour, and 30 days	First 30 days after injury
Hospital Free Days	Number of days out of the hospital	First 30 days after injury
ICU Free Days	Number of days out of the ICU	First 30 days after injury
Ventilator Free Days	Number of days not on a ventilator	First 30 days after injury
Blood Transfusions	The amount of blood products transfused in the first 24 hours	First 24 hours after injury

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Martin A Schreiber, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: June 2, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Mortality; Trauma; Hemorrhage; Wounds and Injuries; Shock, Hemorrhagic
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Shock; Wounds and Injuries; Shock, Hemorrhagic; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: OHSU IRB 17077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No