Clinical trial NCT06627218: Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
Official title: Liberal or Adhere to Recommendations for Prothrombin Complex Concentrate Management in Major Bleeding Following Trauma：A Multicenter Retrospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Bleeding
Keywords: trauma
Major Bleeding
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: in-hospital mortality
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Emergency medicine, Second Affiliated Hospital, School of Medicine& Institute of Emergency medicine, Zhejiang University,
state: Zhejiang
Study officials:
affiliation: Department of Emergency medicine，Second Affiliated Hospital of Zhejiang University
name: yongan xu, doctor
role: STUDY_CHAIR
References: