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

NCT ID: NCT06144099

Condition: Prostate Cancer
Spine, Open
Hip Osteoarthritis
Knee Disease

Conditions: Official terms:
Osteoarthritis, Hip
Spinal Dysraphism
Thrombin

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Biological
Intervention name: fresh frozen plasma
Description: transfusion of fresh frozen plasma
Arm group label: fresh frozen plasma

Intervention type: Biological
Intervention name: prothrombin complex concentrate
Description: prothrombin complex concentrate administration
Arm group label: prothrombin complex concentrate

Summary: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: March 1, 2024

Completion date: April 1, 2025

Lead sponsor:
Agency: Konkuk University Medical Center
Agency class: Other

Source: Konkuk University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06144099

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