A Phase 4 interventional study of fresh frozen plasma and prothrombin complex concentrate in Cardiac Valve Disease, sponsored by Konkuk University Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Treatment
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.
552 studies on the registry are indexed under Heart Valve Diseases; 162 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 311 interventional studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →Konkuk University Medical Center is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, fresh frozen plasma transfusion (FFP) 10-15 ml/kg is performed
Biological: fresh frozen plasma
according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) 10-15 IU/kg is administered
Biological: prothrombin complex concentrate
transfusion of fresh frozen plasma
prothrombin complex concentrate administration
treatment 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
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
Thromboembolism complication
myocardial infarction, stroke, cerebral infarction, bowel ischemia
Time frame: 24 hour
Plan to share: Undecided
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Studies of the drug tested here: Prothrombin complex concentrate
Konkuk University Medical Center