Kcentra for Hemorrhagic Shock

Overseen By Samantha Underwood

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oregon Health and Science University

Must not be taking: Warfarin, Novel anti-coagulants

Disqualifiers: Thromboembolic disorders, Stroke, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

166 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Martin A Schreiber, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for adults over 18 years old who weigh more than 50 kg and are suspected to be in hemorrhagic shock due to injury, with a systolic blood pressure below 70 mmHg. It's not for those with isolated head or spinal injuries, known coagulant use, severe hypothermia, drowning victims, prisoners, significant burns (>20%), pregnant women, recent CPR recipients or thromboembolic disorders.

Inclusion Criteria

I might have severe bleeding due to an injury.

Systolic blood pressure < 70 mmHg

EMS transport to a participating trauma center

Exclusion Criteria

I have a history of blood clots or stroke.

I have had a severe brain injury with very serious symptoms.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Immediate

Treatment

Administration of Kcentra or placebo in the pre-hospital setting to trauma patients with hemorrhagic shock

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ICU, hospital, and ventilator-free days, as well as mortality

30 days

Treatment Details

Interventions

• Kcentra
• Placebo

Trial Overview The study tests if Kcentra (a prothrombin complex concentrate) can be effectively used by EMS in the field for patients with traumatic bleeding. Participants will either receive Kcentra or a placebo to assess its feasibility and administration process during prehospital care.

Participant Groups

Group I: Kcentra Experimental Treatment 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+