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Search / Trial NCT05738642

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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Feb 21, 2023

Trial Information

Current as of November 11, 2025

Not yet recruiting

Keywords

Trauma

ClinConnect Summary

This clinical trial is studying the use of a treatment called four-factor prothrombin complex (4F-PCC) in patients with severe traumatic bleeding. When someone experiences a major injury, they can lose a lot of blood, which can lead to serious complications and increase the risk of death. The researchers want to see if giving 4F-PCC early can help improve blood clotting and overall recovery for patients who are experiencing significant bleeding due to trauma.

To participate in this trial, individuals must be adults aged 18 to 79 who have suffered a severe injury (measured by a specific scoring system) and are bleeding actively. They should also be evaluated within three hours of their injury and expected to need a substantial amount of blood transfusions. However, certain people, such as those with a history of blood clots or severe head injuries, will not be eligible. Participants in the trial can expect to receive the treatment and be monitored closely to see how it affects their recovery. This could be an important step in finding better ways to treat patients with severe trauma and improve their chances of survival.

Gender

ALL

Eligibility 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.

About Second Affiliated Hospital, School Of Medicine, Zhejiang University

The Second Affiliated Hospital of Zhejiang University School of Medicine is a leading clinical research institution dedicated to advancing healthcare through innovative medical practices and rigorous scientific inquiry. With a robust infrastructure and a multidisciplinary team of experienced researchers and clinicians, the hospital is committed to conducting high-quality clinical trials that address critical health challenges. As an integral part of Zhejiang University, the hospital leverages academic expertise and cutting-edge technology to foster collaboration in research, education, and patient care, ultimately aiming to improve patient outcomes and contribute to the global medical community.

Locations

Patients applied

0 patients applied

Trial Officials

yongan xu, doctor

Study Chair

Second Affiliated Hospital, School of Medicine, Zhejiang University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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