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Prehospital Kcentra for Hemorrhagic Shock

Primary Purpose

Trauma Injury

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Prothrombin Complex Concentrate, Human

Placebo

About this trial

This is an interventional treatment trial for Trauma Injury focused on measuring Shock, Hemorrhagic, Trauma, Mortality, Wounds and Injuries, Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Trauma patients age 18 years or greater, or weight > 50 kg if age unknown
Systolic blood pressure < 70 mmHg
Suspicion of hemorrhagic shock based on mechanism of injury
EMS transport to a participating trauma center

Exclusion Criteria:

Age less than 18
Unknown time of injury
Out-of-hospital cardiopulmonary resuscitation
Known history of thromboembolic disorders or stroke or suspicion by EMS of a recent stroke
Known oral anti-coagulant use to include warfarin and novel anti-coagulants
Severe hypothermia (<28°C)
Drowning or asphyxia due to hanging
Burns more than 20% total body surface area
Evidence of devastating blunt traumatic brain injury to include fixed and dilated pupils, asymmetric pupils and extrusion of brain matter
Isolated blunt or penetrating head injury
Isolated spinal cord injury
Ground level (same level) falls
Inability to obtain intravenous access
Inability to administer randomized therapy within 4 hours of ambulance notification
Known transfers and inter-facility transfers
Known Do Not Resuscitate (DNR) prior to randomization
Known or suspected pregnancy
Known prisoners
Patients who have activated the "opt-out" process

Sites / Locations

Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Kcentra

Placebo

Arm Description

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

A single infusion of volume matched placebo solution (Normal Saline)

Outcomes

Primary Outcome Measures

Feasibility of study drug administration

Number of study drug kits opened and given to patients prior to hospital arrival.

Secondary Outcome Measures

Mortality

To evaluate mortality at 3 hour, 24 hour, and 30 days

Hospital Free Days

Number of days out of the hospital

ICU Free Days

Number of days out of the ICU

Ventilator Free Days

Number of days not on a ventilator

Blood Transfusions

The amount of blood products transfused in the first 24 hours

Full Information

NCT ID

NCT04019015

First Posted

June 2, 2019

Last Updated

April 14, 2022

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT04019015

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 15, 2021 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma Injury

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Kcentra

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A single infusion of volume matched placebo solution (Normal Saline)

Intervention Type

Drug

Intervention Name(s)

Prothrombin Complex Concentrate, Human

Other Intervention Name(s)

Kcentra

Intervention Description

Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal saline solution

Primary Outcome Measure Information:

Title

Feasibility of study drug administration

Description

Number of study drug kits opened and given to patients prior to hospital arrival.

Time Frame

First 24 hours after injury

Secondary Outcome Measure Information:

Title

Mortality

Description

To evaluate mortality at 3 hour, 24 hour, and 30 days

Time Frame

First 30 days after injury

Title

Hospital Free Days

Description

Number of days out of the hospital

Time Frame

First 30 days after injury

Title

ICU Free Days

Description

Number of days out of the ICU

Time Frame

First 30 days after injury

Title

Ventilator Free Days

Description

Number of days not on a ventilator

Time Frame

First 30 days after injury

Title

Blood Transfusions

Description

The amount of blood products transfused in the first 24 hours

Time Frame

First 24 hours after injury

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Trauma patients age 18 years or greater, or weight > 50 kg if age unknown Systolic blood pressure < 70 mmHg Suspicion of hemorrhagic shock based on mechanism of injury EMS transport to a participating trauma center Exclusion Criteria: Age less than 18 Unknown time of injury Out-of-hospital cardiopulmonary resuscitation Known history of thromboembolic disorders or stroke or suspicion by EMS of a recent stroke Known oral anti-coagulant use to include warfarin and novel anti-coagulants Severe hypothermia (<28°C) Drowning or asphyxia due to hanging Burns more than 20% total body surface area Evidence of devastating blunt traumatic brain injury to include fixed and dilated pupils, asymmetric pupils and extrusion of brain matter Isolated blunt or penetrating head injury Isolated spinal cord injury Ground level (same level) falls Inability to obtain intravenous access Inability to administer randomized therapy within 4 hours of ambulance notification Known transfers and inter-facility transfers Known Do Not Resuscitate (DNR) prior to randomization Known or suspected pregnancy Known prisoners Patients who have activated the "opt-out" process

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin A Schreiber, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prehospital Kcentra for Hemorrhagic Shock

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