Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
NCT ID: NCT06627218
Last Updated: 2024-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
650 participants
INTERVENTIONAL
2021-01-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Adhere to Recommendations for PCC Management
Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
Prothrombin Complex Concentrate
Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
Liberal PCC Management
Liberal PCC Management in Major Bleeding Following Trauma
No interventions assigned to this group
Interventions
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Prothrombin Complex Concentrate
Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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yongan xu, doctor
Role: STUDY_CHAIR
Department of Emergency medicine，Second Affiliated Hospital of Zhejiang University
Locations
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Department of Emergency medicine, Second Affiliated Hospital, School of Medicine& Institute of Emergency medicine, Zhejiang University,
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-0580
Identifier Type: -
Identifier Source: org_study_id
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