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:
Participant gender:
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
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University