Using prothrombin complex concentrate for major bleeding after trauma

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

This study is testing if a treatment called prothrombin complex concentrate can help people with severe bleeding after a traumatic injury feel better and recover faster.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 650 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06627218 on ClinicalTrials.gov

What this trial studies

This study investigates the use of prothrombin complex concentrate (PCC) in managing severe bleeding and coagulopathy following trauma. It aims to evaluate the effectiveness and safety of PCC in patients treated in resuscitation units or emergency rooms within 24 hours of injury. The study will assess whether adherence to current guidelines for PCC administration improves outcomes in trauma patients experiencing major bleeding. The research addresses a significant gap in clinical data regarding the use of PCC in this context.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced trauma and are admitted to a resuscitation unit or emergency room within 24 hours of their injury.

Not a fit: Patients who have received PCC prior to admission or those with certain anticoagulant therapies or severe coagulation disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment protocols for managing severe traumatic bleeding, potentially saving lives.

How similar studies have performed: Previous studies have shown promising results for PCC in managing traumatic bleeding, but this specific approach is still under-evaluated.

Eligibility criteria

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

Where this trial is running

Hangzhou, Zhejiang

• Department of Emergency medicine, Second Affiliated Hospital, School of Medicine& Institute of Emergency medicine, Zhejiang University, — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: yongan xu, doctor

Conditions: Traumatic Bleeding, trauma, Major Bleeding