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Prehospital Kcentra for Hemorrhagic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04019015
Recruitment Status : Not yet recruiting
First Posted : July 15, 2019
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Martin A Schreiber, MD, Oregon Health and Science University

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.

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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
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019015


Contacts
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Contact: Samantha Underwood 503-494-8481 underwos@ohsu.edu

Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Martin A Schreiber, MD Oregon Health and Science University
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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    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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