A Phase 4 interventional study of fresh frozen plasma and prothrombin complex concentrate in Liver Diseases, sponsored by Konkuk University Medical Center. Not yet recruiting at 1 site in South Korea. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Treatment
We compared the time consumed for goal-directed management of hypofibrinogemia using two strategies during liver transplant (LT) surgery: a conventional cryoprecipitate-based strategy versus a lyophilized fibrinogen concentrate-based strategy
The primary outcome is an inter-group comparison of treatment time (T-time, the duration from ordering cryoprecipitate or FC to completing its administration). The secondary measures include comparisons of perioperative bleeding, blood transfusion, coagulation profiles, reoperation, thromboembolic complications, mortality, oxygenation profiles, fibrinolysis phenotypes, and costs for bleeding management and length of hospital stay.
824 studies on the registry are indexed under Liver Diseases; 152 are open to participants now.
This study's planned enrollment of 92 is above the median of 52 across 521 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Konkuk University Medical Center is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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If serum-fibrinogen \< 100 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), cryoprecipitate is administered
Biological: fresh frozen plasma
If serum-fibrinogen \< 80 mg/dl or CFF-MA \< 15 mm in thromboelastography (TEG), fibrinogen concentrate is administered.
Biological: prothrombin complex concentrate
transfusion of fresh frozen plasma
prothrombin complex concentrate administration
intergroup difference in the treatment time (T-time)
The treatment time (T-time): the duration from ordering cryoprecipitate or FC to completing its administration
Time frame: 1 min
Red Blood Cell amount
Red Blood Cell transfusion amount during surgery
Time frame: 1 hour
FFP amount
FFP transfusion amount during surgery
Time frame: 1 hour
Platelet amount
Platelet transfusion amount during surgery
Time frame: 1 hour
r-time
CK r-time after PCC or FFP
Time frame: 1 min
CRT-MA
CRT-MA after PCC or FFP
Time frame: 1 min
CFF-MA
CFF-MA after PCC or FFP
Time frame: 1 min
Bleeding
Postoperative bleeding amount
Time frame: 6 hour
oxygenation profile
PaO2/FiO2 ratio
Time frame: 1 hour
preparation time of cryoprecipitate or FC
time from the start of preparation (ABO-cross matching and thawing of cryoprecipitate or unpacking FC from its storage) to the delivery to patients in the operation theater
Time frame: 1 min
Plan to share: Undecided
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prothrombin complex concentrate
Konkuk University Medical Center