Cardiac Valve Disease
Conditions
Brief 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 cardiac surgery.
Interventions
BIOLOGICALfresh frozen plasma
transfusion of fresh frozen plasma
BIOLOGICALprothrombin complex concentrate
prothrombin complex concentrate administration
Sponsors
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Patients are randomly divided into two groups (experimental vs control groups).
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* patients undergoing cardiac surgery
Exclusion criteria
* thrombocytopenia * oral anti-coagulant * anti platelet agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment time | 1 min | duration from the time diagnosing CT-EXTEM prolongation to the time achieving bleeding control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FFP amount | 1 hour | Red Blood Cell transfusion amount during surgery |
| Platelet amount | 1 hour | Platelet transfusion amount during surgery |
| CT-EXTEM | 10 min | clotting time-EXTEM after PCC or FFP |
| Red Blood Cell amount | I hour | Red Blood Cell transfusion amount during surgery |
| MA-FIBTEM | 10 min | Maximal amplitude-FIBTEM after PCC or FFP |
| Postoperative bleeding | 24 hour | chest tube drainage at postoperative 24 hour |
| MA-EXTEM | 10 min | Maximal amplitude-EXTEM after PCC or FFP |
Contacts
Primary ContactTae-Yop KIm, MD PhD
Outcome results
None listed