Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery

Konkuk University Medical Center

Status and phase: Not yet enrolling; Phase 4

Conditions: Cardiac Valve Disease

Treatments: Biological: prothrombin complex concentrate; Biological: fresh frozen plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT06144125

HC22195220002004

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients undergoing cardiac surgery

Exclusion criteria

• thrombocytopenia
• oral anti-coagulant
• anti platelet agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups

fresh frozen plasma

Active Comparator group

Description:

according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, fresh frozen plasma transfusion (FFP) is performed

Treatment:

Biological: fresh frozen plasma

prothrombin complex concentrate

Experimental group

Description:

according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) is administered

Treatment:

Biological: prothrombin complex concentrate