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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
transfusion of fresh frozen plasma
prothrombin complex concentrate administration
Konkuk University Medical Center
Seoul, Seoul, South Korea
RECRUITINGtreatment time
duration from the time of diagnosing CT-EXTEM prolongation (ordering PCC or FFP) to the time achieving bleeding control (completing administration of PCC or FFP)
Time frame: 1 min
Red Blood Cell amount
Red Blood Cell transfusion amount during surgery
Time frame: I hour
FFP amount
Red Blood Cell transfusion amount during surgery
Time frame: 1 hour
Platelet amount
Platelet transfusion amount during surgery
Time frame: 1 hour
cryoprecipiate amount
amount of cryoprecipitate transfusion
Time frame: 1 hour
CT-EXTEM change
clotting time-EXTEM after PCC or FFP
Time frame: 1 min
A5-EXTEM change
clot amplitude at 5 min after clot initiation in EXTEM after PCC or FFP
Time frame: 1 min
MCF-EXTEM change
Maximal clot firmness in EXTEM after PCC or FFP
Time frame: 1 min
A5-FIBTEM change
clot amplitude at 5 min after clot initiation in FIBTEM after PCC or FFP
Time frame: 1 min
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Postoperative bleeding
chest tube drainage at postoperative 24 hour
Time frame: 24 hour
Preparation time
from the start of cross-matching and thawing of FFP or unpacking of PCC in its storage area to the time of its delivery to patients in the operating room
Time frame: 1 min
success rate of the 1st coagulation management
incidence of achieving CT-EXTEM \< 80 sec after administering PCC or FFP as coagulation management
Time frame: 10 min