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

Phase 4

Not yet recruiting

• Conditions: Prostate Cancer; Spine, Open; Hip Osteoarthritis; Knee Disease
• Interventions: Biological: fresh frozen plasma; Biological: prothrombin complex concentrate

• Registration Number: NCT06144099
• Lead Sponsor: Konkuk University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02
• Study Start: 2024-03-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fresh frozen plasma	fresh frozen plasma	according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed
prothrombin complex concentrate	prothrombin complex concentrate	according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration

Primary Outcome Measures

Name	Time	Method
duration from the time diagnosing r-time prolongation to the time achieving bleeding control	1 min

Secondary Outcome Measures

Name	Time	Method
r-time	10 min	CK r-time after PCC or FFP
Bleeding	6 hour	Postoperative bleeding amount
oxygenation profile	1 hour	PaO2/FiO2 ratio
Red Blood Cell amount	1 hour	Red Blood Cell transfusion amount during surgery
FFP amount	1 hour	FFP transfusion amount during surgery
CRT-MA	10 min	CRT-MA after PCC or FFP
CFF-MA	10 min	CFF-MA after PCC or FFP
Platelet amount	1 hour	Platelet transfusion amount during surgery