Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2021-01-01
Last updated
2024-10-04
Condition(s) studied
Traumatic Bleeding
Investigational drug(s) / intervention(s)
Prothrombin Complex Concentrate
Prothrombin Complex Concentrate: Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years old or \< 80 years old
2. Trauma treated in resuscitation unit/emergency room patient
3. Hospital admission within 24h after injury
4. Assessment of blood consumption (ABC) score ≥2 points.
Exclusion Criteria:
1. PCC was used before admission
2. Anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.)
3. Previous venous thrombosis (VTE, Patients with a history of coronary artery stents within 3 months of pulmonary embolism and myocardial infarction)
4. Patients with traumatic cardiac arrest in hospital
5. Women during breastfeeding, pregnancy or pregnancy
6. Patients with hemophilia A and other blood system diseases, severe liver disease, cirrhosis and other coagulation dysfunction
Primary outcome measure(s)
in-hospital mortality — 14 days in-hospital mortality
Trial sites (1)
Facility
City
Region
Status
Department of Emergency medicine, Second Affiliated Hospital, School of Medicine& Institute of Emergency medicine, Zhejiang University,
Hangzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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