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NCT06144112 Clinical Trial

Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Liver Transplantation Surgery

Liver Diseases Clinical Trial

Official title:
Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Liver Transplantation Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06144112
Other study ID # HC22195220002003
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2024
Est. completion date April 1, 2025

Study information
Verified date November 2023
Source Konkuk University Medical Center
Contact Tae-Yop Kim, MD PhD
Phone +82-10-8811-6942
Email taeyop@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for liver transplantation surgery.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 92
Est. completion date April 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - Liver disease undergoing Liver transplantation Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• fresh frozen plasma
transfusion of fresh frozen plasma
• prothrombin complex concentrate
prothrombin complex concentrate administration

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Konkuk University Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary duration from the time diagnosing r-time prolongation to the time achieving bleeding control 1 min
Secondary Red Blood Cell amount Red Blood Cell transfusion amount during surgery 1 hour
Secondary FFP amount FFP transfusion amount during surgery 1 hour
Secondary Platelet amount Platelet transfusion amount during surgery 1 hour
Secondary r-time CK r-time after PCC or FFP 10 min
Secondary CRT-MA CRT-MA after PCC or FFP 10 min
Secondary CFF-MA CFF-MA after PCC or FFP 10 min
Secondary Bleeding Postoperative bleeding amount 6 hour
Secondary oxygenation profile PaO2/FiO2 ratio 1 hour
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