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

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ClinicalTrials.gov Identifier: NCT05738642
Recruitment Status : Not yet recruiting
First Posted : February 22, 2023
Last Update Posted : February 22, 2023
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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 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.


Condition or disease Intervention/treatment Phase
Trauma Drug: 4 factor Prothrombin Complex Concentrates Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Efficacy of Early Bunching of a Four-factor Prothrombin Complex Concentrates in Patients With Severe Traumatic Hemorrhage: a Multicenter, Randomized Controlled, Open-label Clinical Study
Estimated Study Start Date : March 1, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4F-PCC group
1. Basic and normative treatment in accordance with the European Guidelines for Major Bleeding 2019: effective hemostatic measures and target-oriented correction of coagulation function. 2. 4 F- PCC by intravenous infusion of cluster
Drug: 4 factor Prothrombin Complex Concentrates
Cluster 4 f - PCC by intravenous infusion (boya 4 f - PCC, a bottle of 400 IU) : 25 IU/kg dose infusion time: as soon as possible after admission infusion, at the latest within 2 hours after admission to infusion infusion method: Sodium chloride injection 5% glucose injection was diluted into 50 ml per bottle, and then intravenous infusion was carried out with a blood transfusion device with a mesh device. The infusion was finished in 60-120 minutes
Other Name: test group

No Intervention: non 4F-PCC group
1. Basic and normative treatment in accordance with the European Guidelines for Major Bleeding 2019: effective hemostatic measures and target-oriented correction of coagulation function.



Primary Outcome Measures :
  1. Incidence of multiple organ failure within 7 days [ Time Frame: 7 days ]
  2. mortality at 28 days [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. The total transfusion volume of blood products within 24 hours after trauma [ Time Frame: 28 days ]
    The total transfusion volume of blood products within 24 hours after trauma



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05738642


Contacts
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Contact: yongan xu, doctor 13757164833 xuyongan2000@163.com

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: yongan xu, doctor Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT05738642    
Other Study ID Numbers: 2022-0955
First Posted: February 22, 2023    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
trauma
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Thrombin
Hemostatics
Coagulants