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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Kcentra for individuals experiencing hemorrhagic shock, a severe loss of blood. Researchers aim to determine if emergency medical services (EMS) can successfully identify patients in shock and administer Kcentra while still in the field. Participants will receive either a dose of Kcentra or a placebo (a non-active substance) to compare results. Ideal candidates for this trial are trauma patients with very low blood pressure (under 70 mmHg) who EMS transports to a trauma center. As a Phase 2 trial, this research measures how well Kcentra works in an initial, smaller group of people, offering participants a chance to contribute to potentially life-saving advancements.

Will I have to stop taking my current medications?

If you are currently taking oral anti-coagulants like warfarin, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Kcentra, a medication used to aid blood clotting, has been studied for safety in various situations. One study found Kcentra generally safe for patients at risk of heavy bleeding due to injury, with most not experiencing serious side effects. Another study confirmed Kcentra's consistent safety across different patient groups, including those with various blood conditions.

Further reviews support Kcentra's safety for its approved uses, and long-term data suggest it is generally safe. Some patients might experience mild side effects, but serious reactions are rare. The FDA has already approved Kcentra for other uses, indicating a strong safety record.

Overall, evidence suggests Kcentra is mostly safe for people, with a low risk of serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for hemorrhagic shock, which often involves blood transfusions and fluid resuscitation, Kcentra offers a more targeted approach. Kcentra is a four-factor prothrombin complex concentrate that provides quick replenishment of essential clotting factors, which are often depleted in severe bleeding scenarios. This treatment is unique because it can be administered rapidly and in a single dose, potentially leading to faster stabilization of patients compared to traditional methods. Researchers are excited about Kcentra because it may significantly reduce bleeding and improve survival rates more effectively and efficiently than existing treatments.

What evidence suggests that Kcentra might be an effective treatment for hemorrhagic shock?

Research has shown that Kcentra, a medication containing four key blood-clotting factors, effectively controls bleeding. Studies demonstrate that it enhances the body's ability to form blood clots, crucial for stopping bleeding. In this trial, participants will receive either Kcentra or a placebo. In trauma patients at risk of severe bleeding, early use of Kcentra proved both effective and safe. This treatment is often used for conditions like brain bleeding, making Kcentra a promising option for treating severe blood loss, where quick clot formation is essential. ^{1 3 4 6 7}

Who Is on the Research Team?

Martin A Schreiber, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11723492/

Four-factor Prothrombin Complex Concentrate Use for ... The clinical use of four-factor prothrombin complex concentrate in adult trauma patients at risk of bleeding is supported by evidence for urgent reversal of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1473050225000497

Twenty years of the four-factor prothrombin complex ... Prothrombin complex concentrate (PCC) is used to boost thrombin potential, support clot formation, and aid in the treatment and prophylaxis of bleeding.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10031505/

Efficacy and Safety of Early Administration of 4-Factor ... Efficacy and safety of early administration of 4-factor prothrombin complex concentrate in patients with trauma at risk of massive transfusion.

4. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-023-04688-z

Prothrombin complex concentrate (PCC) for treatment of ... The overall aim of this systematic review was to investigate the outcomes and safety of PCC in major trauma patients with TIC. The primary ...

5. link.springer.com link.springer.com/article/10.1007/s40119-024-00357-6

Real-World Safety and Effectiveness of a 4-Factor ... The most common reason for 4F-PCC administration was intracranial hemorrhage (59.6%), followed by gastrointestinal bleeding (6.6%).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11333383/

Safety and Effectiveness of Four-Factor Prothrombin ... The study revealed that the safety and effectiveness of 4F-PCC in Japanese patients were consistent between INR < 2.0 and ≥ 2.0, although no ...

7. thieme-connect.com thieme-connect.com/products/ejournals/pdf/10.1055/s-0044-1788305.pdf

Long-Term Safety of a Four-Factor Prothrombin Complex ... In this review, we aim to evaluate the safety profile of a 4F-PCC (Kcentra®/Beriplex® P/N; CSL Behring, Marburg, Germany) by reviewing.