Efficacy and Safety of Early Use PCC in Severe Trauma

NCT05738642 | Completed

• 1 other identifier: 2023-0029
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

Uncontrolled hemorrhage within 24 hours after severe trauma is the main cause of death in trauma patients. Hemorrhagic shock may be accompanied by traumatic coagulopathy in the early stages of severe trauma. Among them, the main pathogenesis of traumatic coagulation disorder is tissue injury, hypoperfusion, inflammatory response and , increased consumption of coagulation factor, loss of coagulation factor caused by massive bleeding, low temperature and other factors aggravate the disorder of coagulation function and cause hyperfibrinolysis. Studies have shown that the fatality rate of patients with severe traumatic coagulopathy is 4-8 times higher than that of patients without coagulopathy. Active and effective injury-controlled resuscitation and surgical treatment, target-oriented supplementation of coagulation substrate and correction of coagulation function are the main measures for high-quality treatment of patients with severe trauma. Therefore, early improvement of coagulation function is the key to improve the comprehensive treatment level of patients with severe trauma. At present, four-factor prothrombin complex (4F-PCC) is a compound preparation containing coagulation factors Ⅱ, VII, IX and X separated from fresh plasma of healthy people. However, large-scale, long-term observation of the efficacy and safety of the early application of 4F-PCC in traumatic massive hemorrhage has not been proven. In this study, it is to study the efficacy and safety of early use of 4F-PCC in patients with severe traumatic massive hemorrhage through a multi-center, randomized controlled and open-label clinical trial.

Conditions

Severe Trauma; Traumatic Shock

Keywords

trauma; injury; Hemorrhagic shock

Outcome Measures

Primary Outcomes (2)

• Incidence of multiple organ failure within 7 days

  Incidence of multiple organ failure within 7 days after enrollment

  within 7 days after enrollment

• Day 28-mortality

  the mortality within Day 28 after enrollment

  within Day 28 after enrollment

Secondary Outcomes (18)

• The total volume of blood products within 24 hours after trauma

  within 24 hours after admission

• The total volume of blood products within Day 3 after trauma

  within Day 3 after admission

• The total volume of coagulation substrate within Day 1 after trauma

  within Day 1 after admission

• The total volume of coagulation substrate within Day 3 after trauma

  within Day 3 after admission

• Incidence of thrombotic events at early stage

  DAY 2 after admission

Study Arms (2)

Treatment of prothrombin complex concentrate

EXPERIMENTAL

Based on the treatment plan of the control group, a single frequency of intravenous infusion of 4F-PCC was added. Therapeutic dose: 25 IU/kg. Infusion time: starting within 2 hours after admission Infusion method: Each bottle of 4F-PCC should be injected with a sterile solution pre-warmed to 20\~30℃. Dilute with water to 25ML solution, then use a filter with the required amount of solution. The infusion is completed within 60 minutes. Basic treatment according to "The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition".

Drug: 4 factor Prothrombin Complex Concentrates

control group by Basic treatment

NO INTERVENTION

Basic treatment according to "The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition".

Interventions

4 factor Prothrombin Complex Concentrates DRUG

Based on the treatment plan of the control group, a single frequency of intravenous infusion of 4F-PCC (Boya) was added. Therapeutic dose: 25 IU/kg (rich in FVII, IX, II, and X) Infusion time: infusion as soon as possible, starting within 2 hours after admission at the latest Infusion method: Each bottle of 4F-PCC should be injected with a sterile solution pre-warmed to 20\~30℃. Dilute with water to 25ML solution, then use a filter with the required amount of solution The device's blood transfusion device performs intravenous infusion, and the infusion is completed within 60 minutes.

Treatment of prothrombin complex concentrate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Jinhua Municipal Central Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• Ningbo No.2 Hospital: collaborator
• Lishui Country People's Hospital: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Shaoxing People's Hospital: collaborator
• The Third Affiliated Hospital of Wenzhou Medical University: collaborator
• The People's Hospital of Quzhou: collaborator

Study Sites (1)

Yongan Xu

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Wounds and Injuries; Shock, Traumatic; Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Study Officials

• yongan xu, doctor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-consultant

Model Details: A Multicenter, prospective, open-label, randomized controlled clinical study

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: August 10, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)