Prehospital Kcentra for Hemorrhagic Shock

NCT04019015 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: OHSU IRB 17077
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of study drug administration

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

  First 24 hours after injury

Secondary Outcomes (5)

• Mortality

  First 30 days after injury

• Hospital Free Days

  First 30 days after injury

• ICU Free Days

  First 30 days after injury

• Ventilator Free Days

  First 30 days after injury

• Blood Transfusions

  First 24 hours after injury

Study Arms (2)

Kcentra

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Prothrombin Complex Concentrate, Human DRUG

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

Also known as: Kcentra

Kcentra

Placebo DRUG

Normal saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Accidental Injuries; Shock, Hemorrhagic; Wounds and Injuries; Hemorrhage

Interventions

Factor IX

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Martin A Schreiber, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of Trauma

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: July 15, 2019
• Study Start: March 15, 2021
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)