Could a clotting factor shot save trauma patients from organ failure?
NCT ID NCT05738642
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving a clotting factor concentrate (4F-PCC) early to people with severe traumatic bleeding could reduce organ failure and death. 380 patients were randomly assigned to receive either standard care or standard care plus 4F-PCC within 2 hours of hospital arrival. The goal was to see if the drug improves survival and lowers the need for blood transfusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- four-factor prothrombin complex concentrate (4F-PCC)
- What this could lead to
- If it works, this could provide a new early treatment to improve survival and reduce organ failure in severe trauma patients with major bleeding.
- What could go wrong
- This is a completed trial, but results are not yet widely reported. The treatment may not significantly improve outcomes over standard care, and there is a risk of clotting complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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380 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years, or \< 80 years * Grade of triage: 1-2 * \<3 hours after injury * Assessment of blood consumption(ABC) score ≥2; Or an estimated infusion of 3 units of concentrated red blood cells within 1 hour after admission; or 10 units of concentrated red blood cells within 24 hours after admission * Obtain the informed consent of the patient Exclusion criteria : * PCC was used before admission * Taking anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.) * History of deep vein thrombosis (VTE, pulmonary embolism (PE) and myocardial infarction History of coronary stent within 6 months * Patients who suffered cardiac arrest upon admission and before enrollment * Have a history of heparin allergy or heparin-induced thrombocytopenia * Allergic to PCC * Women who are lactating, pregnant, or pregnant * Patients with various mental illnesses lose their capacity for civil conduct * Hemophilia A and other blood system diseases, severe liver disease, cirrhosis and other blood coagulation * No capacity for civil right
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Yongan Xu
Hangzhou, Zhejiang, 310009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.