Prostate Cancer, Spine, Open, Hip Osteoarthritis, Knee 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 non-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)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* patients undergoing spine surgery * patients undergoing open radical prostatectomy * patients undergoing hip arthroplasty * patients undergoing knee arthroplasty
Exclusion criteria
* Patients taking oral anticoagulants, * Patient taking recombinant factor VII a * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration from the time diagnosing r-time prolongation to the time achieving bleeding control | 1 min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FFP amount | 1 hour | FFP transfusion amount during surgery |
| Platelet amount | 1 hour | Platelet transfusion amount during surgery |
| r-time | 10 min | CK r-time after PCC or FFP |
| Red Blood Cell amount | 1 hour | Red Blood Cell transfusion amount during surgery |
| CFF-MA | 10 min | CFF-MA after PCC or FFP |
| Bleeding | 6 hour | Postoperative bleeding amount |
| oxygenation profile | 1 hour | PaO2/FiO2 ratio |
| CRT-MA | 10 min | CRT-MA after PCC or FFP |
Contacts
Primary ContactTae-Yop Kim, MD PhD
Outcome results
None listed