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出境医 / 临床实验 / Prehospital Kcentra for Hemorrhagic Shock

Prehospital Kcentra for Hemorrhagic Shock

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
Layout table for study information
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 : March 15, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022
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
Layout table for eligibility information
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

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

Sponsors and Collaborators
Oregon Health and Science University
Investigators
Layout table for investigator information
Principal Investigator: Martin A Schreiber, MD Oregon Health and Science University
Tracking Information
First Submitted Date  ICMJE June 2, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date March 8, 2021
Estimated Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prehospital Kcentra for Hemorrhagic Shock
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Trauma Injury
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019) 		166
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samantha Underwood 503-494-8481 underwos@ohsu.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019015
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Martin A Schreiber, MD, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin A Schreiber, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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