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

Konkuk University Medical Center

Status and phase: Not yet enrolling; Phase 4

Conditions: Hip Osteoarthritis; Spine, Open; Knee Disease; Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06144099

HC22195220002002

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 non-cardiac surgery.

Enrollment: 154 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients undergoing spine surgery
• patients undergoing open radical prostatectomy
• patients undergoing hip arthroplasty
• patients undergoing knee arthroplasty

Exclusion criteria

• Patients taking oral anticoagulants,
• Patient taking recombinant factor VII a
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups

fresh frozen plasma

Active Comparator group

Description:

according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed

Treatment:

Biological: fresh frozen plasma

prothrombin complex concentrate

Experimental group

Description:

according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration

Treatment:

Biological: prothrombin complex concentrate