Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
1 other identifier
interventional
650
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 2, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedOctober 4, 2024
September 1, 2024
5 years
October 2, 2024
October 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
in-hospital mortality
in-hospital mortality
14 days
Study Arms (2)
Adhere to Recommendations for PCC Management
EXPERIMENTALAdhere to Recommendations for PCC Management in Major Bleeding Following Trauma
Liberal PCC Management
NO INTERVENTIONLiberal PCC Management in Major Bleeding Following Trauma
Interventions
Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Emergency medicine, Second Affiliated Hospital, School of Medicine& Institute of Emergency medicine, Zhejiang University,
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
yongan xu, doctor
Department of Emergency medicine，Second Affiliated Hospital of Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2024
First Posted
October 4, 2024
Study Start
January 1, 2021
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
October 4, 2024
Record last verified: 2024-09