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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06144099
• Other study ID #: HC22195220002002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: December 2023
• Source: Konkuk University Medical Center
• Contact: Tae-Yop Kim, MD PhD
• Phone: +82-10-8811-6942
• Email: taeyop[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 154
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Disease
• Osteoarthritis, Hip
• Prostate Cancer
• Spinal Dysraphism

Intervention

Biological:
• fresh frozen plasma
transfusion of fresh frozen plasma
• prothrombin complex concentrate
prothrombin complex concentrate administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration from the time diagnosing r-time prolongation to the time achieving bleeding control		1 min
Secondary	Red Blood Cell amount	Red Blood Cell transfusion amount during surgery	1 hour
Secondary	FFP amount	FFP transfusion amount during surgery	1 hour
Secondary	Platelet amount	Platelet transfusion amount during surgery	1 hour
Secondary	r-time	CK r-time after PCC or FFP	10 min
Secondary	CRT-MA	CRT-MA after PCC or FFP	10 min
Secondary	CFF-MA	CFF-MA after PCC or FFP	10 min
Secondary	Bleeding	Postoperative bleeding amount	6 hour
Secondary	oxygenation profile	PaO2/FiO2 ratio	1 hour