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NCT Number: NCT06627218

Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma

Severe post-traumatic bleeding remains a major challenge in trauma management . The effectiveness and safety of PCC in the treatment of major traumatic bleeding is controversial, and the indications for use are not clear. Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Emergency medicine, Second Affiliated Hospital, School of Medicine& Institute of Emergency medicine, Zhejiang University,

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

yongan xu, doctor

CONTACT

[email protected]

13757164833

About this study

Post-traumatic severe bleeding and associated traumatic coagulopathy remains a challenge.

The use of prothrombin complex concentrate (PCC) is being explored in the management of on-going coagulopathy following trauma, with the cited purpose of boosting thrombin generation. Clinical data on the efficacy of PCC as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis.

Certainly, the utility of PCC was a residual question in the management of traumatic coagulopathy. Uncertainty remains on the indication of use.The 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that PCC should be administered to the bleeding patient based on evidence of delayed coagulation initiation using VEM, provided that fibrinogen levels are normal. The recommendation Grade is 2C.Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old or < 80 years old
  • Trauma treated in resuscitation unit/emergency room patient
  • Hospital admission within 24h after injury
  • Assessment of blood consumption (ABC) score ≥2 points.

Exclusion criteria

  • PCC was used before admission
  • Anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.)
  • Previous venous thrombosis (VTE, Patients with a history of coronary artery stents within 3 months of pulmonary embolism and myocardial infarction)
  • Patients with traumatic cardiac arrest in hospital
  • Women during breastfeeding, pregnancy or pregnancy
  • Patients with hemophilia A and other blood system diseases, severe liver disease, cirrhosis and other coagulation dysfunction

Treatment and study plan

Prothrombin Complex Concentrate

Drug

Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma

Other names: test group

Primary outcomes

  1. in-hospital mortality

    Time frame: 14 days

    in-hospital mortality

Study contacts

Contact information is provided by the study sponsor or research team.

yangbo kang, master

CONTACT

[email protected]

19858878803

yongan xu, doctor

CONTACT

[email protected]

13757164833

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Liberal or Adhere to Recommendations for Prothrombin Complex Concentrate Management in Major Bleeding Following Trauma:A Multicenter Retrospective Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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