Evaluation of the Efficacy of Early Bunching of a FF-PCC in Patients With Severe Traumatic Hemorrhage

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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 acute neurohumoral system activation leading to the activation of endogenous protein C, 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. It is used in clinical treatment of patients with coagulation factor deficiency or bleeding complicated by taking anticoagulant drugs to achieve rapid hemostasis effect. However, large-scale, long-term observation of the efficacy and safety of the early application of cluster infusion of 4F-PCC in traumatic massive hemorrhage, correction of cocoagulation dysfunction, and improvement of clinical prognosis has not been proven.

This study intends to conduct a clinical intervention study on early bunching and sufficient use of 4F-PCC in patients with severe traumatic massive hemorrhage, and evaluate its efficacy in early use of severe traumatic massive hemorrhage through a randomized controlled and open-label clinical study of multi-center, bunching use of PCC in patients with severe traumatic massive hemorrhage.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Thrombin

Criteria

Inclusion Criteria:

(1) The age of adult trauma patients ≥18 years, < The 80 - year - old (2) ISS> 16 (3) emergency preview class for 1 to 2; (4) after trauma & lt; 3 hours; Trauma induced active bleeding; (5) blood consumption (ABC) score of 2 or more, or a preliminary assessment of blood loss & gt; 1000ml or ≥4 units of red blood cells expected to be transfused

Exclusion Criteria:

(1) history of anticoagulation and antiplatelet drugs (2) has a deep venous thromboembolism (VTE) and pulmonary embolism (PE) history (3) (4) on patients with severe head injury occurred cardiac arrest patients (5) lactation, pregnant women 6 Abdominal cavity viscera perforation surgical treatment in patients with 7) in patients with sepsis shock patients with all kinds of mental illness incapacitated pet-name ruby are unknown agent for informed consent.