Prehospital Kcentra for Hemorrhagic Shock

• ClinicalTrials.gov Identifier: NCT04019015
• Recruitment Status: Active, not recruiting
• First Posted: July 15, 2019
• Last Update Posted: December 15, 2023
• Sponsor: Oregon Health and Science University
• Information provided by (Responsible Party): Martin A Schreiber, MD, Oregon Health and Science University

Tracking Information

• First Submitted Date: June 2, 2019
• First Posted Date: July 15, 2019
• Last Update Posted Date: December 15, 2023
• Actual Study Start Date: March 15, 2021
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 11, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 11, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prehospital Kcentra for Hemorrhagic Shock
• Official Title: A Prospective Randomized Prehospital Trial Comparing Kcentra Plus Standard of Care to Standard of Care Alone in Trauma Patient With Hemorrhagic Shock
• 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.
• 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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Trauma Injury

Intervention

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

Study Arms

• 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
  Intervention: Drug: Prothrombin Complex Concentrate, Human
• Placebo Comparator: Placebo
  A single infusion of volume matched placebo solution (Normal Saline)
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 11, 2019): 166
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2025
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04019015
• Other Study ID Numbers: OHSU IRB 17077
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Martin A Schreiber, MD, Oregon Health and Science University
• Original Responsible Party: Same as current
• Current Study Sponsor: Oregon Health and Science University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Oregon Health and Science University
• Verification Date: December 2023