Cardiac Valve Disease Clinical Trial
Official title:
Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Cardiac 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 cardiac surgery.
Status | Not yet recruiting |
Enrollment | 152 |
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: - patients undergoing cardiac surgery Exclusion Criteria: - thrombocytopenia - oral anti-coagulant - anti platelet agents |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Konkuk University Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | treatment time | duration from the time diagnosing CT-EXTEM prolongation to the time achieving bleeding control | 1 min | |
Secondary | Red Blood Cell amount | Red Blood Cell transfusion amount during surgery | I hour | |
Secondary | FFP amount | Red Blood Cell transfusion amount during surgery | 1 hour | |
Secondary | Platelet amount | Platelet transfusion amount during surgery | 1 hour | |
Secondary | CT-EXTEM | clotting time-EXTEM after PCC or FFP | 10 min | |
Secondary | MA-EXTEM | Maximal amplitude-EXTEM after PCC or FFP | 10 min | |
Secondary | MA-FIBTEM | Maximal amplitude-FIBTEM after PCC or FFP | 10 min | |
Secondary | Postoperative bleeding | chest tube drainage at postoperative 24 hour | 24 hour |
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