Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery
Phase 4
Not yet recruiting
- Conditions
- Cardiac Valve Disease
- Interventions
- Biological: prothrombin complex concentrateBiological: fresh frozen plasma
- Registration Number
- NCT06144125
- Lead Sponsor
- Konkuk University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 152
Inclusion Criteria
- patients undergoing cardiac surgery
Exclusion Criteria
- thrombocytopenia
- oral anti-coagulant
- anti platelet agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description prothrombin complex concentrate prothrombin complex concentrate according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) is administered fresh frozen plasma fresh frozen plasma according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, fresh frozen plasma transfusion (FFP) is performed
- Primary Outcome Measures
Name Time Method treatment time 1 min duration from the time diagnosing CT-EXTEM prolongation to the time achieving bleeding control
- Secondary Outcome Measures
Name Time Method MA-EXTEM 10 min Maximal amplitude-EXTEM after PCC or FFP
MA-FIBTEM 10 min Maximal amplitude-FIBTEM after PCC or FFP
Red Blood Cell amount I hour Red Blood Cell transfusion amount during surgery
Postoperative bleeding 24 hour chest tube drainage at postoperative 24 hour
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