- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06144112
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Liver Transplantation Surgery
November 16, 2023 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center
Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Liver Transplantation Surgery
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
92
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tae-Yop Kim, MD PhD
- Phone Number: +82-10-8811-6942
- Email: taeyop@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Liver disease undergoing Liver transplantation
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: fresh frozen plasma
according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed
|
transfusion of fresh frozen plasma
|
Experimental: prothrombin complex concentrate
according to the Thromboelastography (TEG) test, CK r-time prolongation, prothrombin complex concentrate (PCC) is administered
|
prothrombin complex concentrate administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
duration from the time diagnosing r-time prolongation to the time achieving bleeding control
Time Frame: 1 min
|
1 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet amount
Time Frame: 1 hour
|
Platelet transfusion amount during surgery
|
1 hour
|
Red Blood Cell amount
Time Frame: 1 hour
|
Red Blood Cell transfusion amount during surgery
|
1 hour
|
FFP amount
Time Frame: 1 hour
|
FFP transfusion amount during surgery
|
1 hour
|
r-time
Time Frame: 10 min
|
CK r-time after PCC or FFP
|
10 min
|
CRT-MA
Time Frame: 10 min
|
CRT-MA after PCC or FFP
|
10 min
|
CFF-MA
Time Frame: 10 min
|
CFF-MA after PCC or FFP
|
10 min
|
Bleeding
Time Frame: 6 hour
|
Postoperative bleeding amount
|
6 hour
|
oxygenation profile
Time Frame: 1 hour
|
PaO2/FiO2 ratio
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
November 16, 2023
First Submitted That Met QC Criteria
November 16, 2023
First Posted (Estimated)
November 22, 2023
Study Record Updates
Last Update Posted (Estimated)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HC22195220002003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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