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Prothrombin Complex Concentrate

Prothrombin Complex Concentrate, Human for Traumatic Injury

Phase 2
Waitlist Available
Led By Martin A Schreiber, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Suspicion of hemorrhagic shock based on mechanism of injury
Trauma patients age 18 years or greater, or weight > 50 kg if age unknown
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 24 hours after injury
Awards & highlights

Study Summary

This trial is testing if it's possible for emergency medical services to give a patient a medication called Kcentra to treat shock.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of Kcentra in this emergency setting aren't listed here, generally it may include allergic reactions, clotting complications like deep vein thrombosis or pulmonary embolism, and possibly increased risk of heart attack or stroke.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I might have severe bleeding due to an injury.
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I am 18 or older, or weigh more than 50 kg if my age is unknown.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 24 hours after injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and first 24 hours after injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of study drug administration
Secondary outcome measures
Blood Transfusions
Hospital Free Days
ICU Free Days
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KcentraExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
A single infusion of volume matched placebo solution (Normal Saline)

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
6,845,863 Total Patients Enrolled
Martin A Schreiber, MDPrincipal InvestigatorOregon Health and Science University
1 Previous Clinical Trials
606 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being accepted for this research?

"Unfortunately, this study is not admitting patients at the moment. However, there are 780 other clinical trials for shock and hemorrhagic patients as well as 12 for Prothrombin Complex Concentrate, Human that are currently enrolling participants."

Answered by AI

Is this the first experiment of its kind to use Prothrombin Complex Concentrate, Human?

"Currently, there are 12 ongoing clinical trials related to Prothrombin Complex Concentrate, Human. Out of these investigations, 5 have reached Phase 3 status. Although a few of the studies are situated in Atlanta, Georgia; overall, there are 75 different research sites running trials for Prothrombin Complex Concentrate, Human."

Answered by AI

What is the primary indication for Prothrombin Complex Concentrate, Human?

"Prothrombin Complex Concentrate, Human is effective in treating factor x deficiency and conditions like hemorrhage, hemophilia b, and prophylaxis of perioperative bleeding."

Answered by AI

Has a similar study been conducted before?

"Since 2018, there has been an growing body of research surrounding Prothrombin Complex Concentrate, Human. After the first Phase 3 trial in 2018 that had 60 participants, the drug received approval. Now, across 9 different countries and 38 cities, there are 12 active trials for Prothrombin Complex Concentrate, Human ."

Answered by AI

How many people are allowed to join this trial?

"This study has wrapped up recruiting participants. The original posting for the clinical trial was on March 15th, 2021 with the most recent update being on April 14th, 2022. For individuals still exploring their options, there are presently 780 trials actively recruiting patients with shock and hemorrhagic conditions as well as 12 studies specifically for Prothrombin Complex Concentrate, Human that need test subjects."

Answered by AI

Are there any dangers associated with Prothrombin Complex Concentrate, Human?

"There is some data indicating that Prothrombin Complex Concentrate, Human is safe, but none yet demonstrating its efficacy. This gives it a safety score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prehospital Kcentra for Hemorrhagic Shock
Martin A Schreiber, MD 2021. "Prehospital Kcentra for Hemorrhagic Shock". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04019015.
~30 spots leftby Dec 2024
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