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Prehospital Kcentra for Hemorrhagic Shock

NCT ID: NCT04019015

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Trauma Injury

Keywords

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Shock, Hemorrhagic Trauma Mortality Wounds and Injuries Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Prothrombin Complex Concentrate, Human

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal saline solution

Interventions

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Prothrombin Complex Concentrate, Human

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

Intervention Type DRUG

Placebo

Normal saline solution

Intervention Type DRUG

Other Intervention Names

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Kcentra

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Martin A Schreiber, MD

Professor and Chief of Trauma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin A Schreiber, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OHSU IRB 17077

Identifier Type: -

Identifier Source: org_study_id