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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04019015
• Other study ID #: OHSU IRB 17077
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 15, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: December 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 166
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock, Hemorrhagic
• Trauma Injury
• Wounds and Injuries

Intervention

Drug:
• Prothrombin Complex Concentrate, Human
Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors
• Placebo
Normal saline solution

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

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