Prehospital Kcentra for Hemorrhagic Shock

• ClinicalTrials.gov Identifier: NCT04019015
• Recruitment Status: Active, not recruiting
• First Posted: July 15, 2019
• Last Update Posted: April 18, 2022
• Sponsor: Oregon Health and Science University
• Information provided by (Responsible Party): Martin A Schreiber, MD, Oregon Health and Science University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Trauma Injury	Drug: Prothrombin Complex Concentrate, Human; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Prehospital Trial Comparing Kcentra Plus Standard of Care to Standard of Care Alone in Trauma Patient With Hemorrhagic Shock
• Actual Study Start Date: March 15, 2021
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: September 2023

Arms and Interventions

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 Name: Kcentra
Placebo Comparator: Placebo; A single infusion of volume matched placebo solution (Normal Saline)	Drug: Placebo; Normal saline solution

Outcome Measures

Primary Outcome Measures :

1. Feasibility of study drug administration [ Time Frame: First 24 hours after injury ]
   Number of study drug kits opened and given to patients prior to hospital arrival.

Secondary Outcome Measures :

1. Mortality [ Time Frame: First 30 days after injury ]
   To evaluate mortality at 3 hour, 24 hour, and 30 days
2. Hospital Free Days [ Time Frame: First 30 days after injury ]
   Number of days out of the hospital
3. ICU Free Days [ Time Frame: First 30 days after injury ]
   Number of days out of the ICU
4. Ventilator Free Days [ Time Frame: First 30 days after injury ]
   Number of days not on a ventilator
5. Blood Transfusions [ Time Frame: First 24 hours after injury ]
   The amount of blood products transfused in the first 24 hours

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Investigators

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

More Information

• Responsible Party: Martin A Schreiber, MD, Professor and Chief of Trauma, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT04019015
• Other Study ID Numbers: OHSU IRB 17077
• First Posted: July 15, 2019
• Last Update Posted: April 18, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martin A Schreiber, MD, Oregon Health and Science University:

Shock, Hemorrhagic; Trauma; Mortality; Wounds and Injuries; Hemorrhage

Additional relevant MeSH terms:

Shock, Hemorrhagic; Wounds and Injuries; Shock; Pathologic Processes; Hemorrhage; Thrombin; Hemostatics; Coagulants