Efficacy and Safety of Early Use PCC in Severe Trauma

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

Interventions

DRUG

4 factor Prothrombin Complex Concentrates

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.

Sponsors & Collaborators

• Jinhua Municipal Central Hospital

  collaborator OTHER

• Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• Ningbo No.2 Hospital

  collaborator OTHER

• Lishui Country People's Hospital

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Shaoxing People's Hospital

  collaborator OTHER

• The Third Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The People's Hospital of Quzhou

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• yongan xu, doctor · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-10

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• China

Study Locations