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Clinical trial

Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Cardiac Surgery

ID
Name
HC22195220002004
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2025-04-01
Trial end
2025-04-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
fresh frozen plasma
transfusion of fresh frozen plasma
Arms:
fresh frozen plasma
prothrombin complex concentrate
prothrombin complex concentrate administration
Arms:
prothrombin complex concentrate
Size
152
Primary endpoint
treatment time
1 min
Eligibility criteria
Inclusion Criteria: * patients undergoing cardiac surgery Exclusion Criteria: * thrombocytopenia * oral anti-coagulant * anti platelet agents
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are randomly divided into two groups (experimental vs control groups).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 152, 'type': 'ESTIMATED'}}
Updated at
2023-11-22

1 organization

2 products

1 indication

Organization
Konkuk University Medical Center
Product
Fresh Frozen Plasma
Indication
Valvular Heart Disease
Product
Prothrombin Complex Concentrate