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NCT06144125 Clinical Trial

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

Cardiac Valve Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06144125
Other study ID # HC22195220002004
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2024
Est. completion date April 1, 2025

Study information
Verified date November 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
Health authority
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 cardiac surgery.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 152
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 75 Years
Eligibility Inclusion Criteria: - patients undergoing cardiac surgery Exclusion Criteria: - thrombocytopenia - oral anti-coagulant - anti platelet agents

Study Design

Related Conditions & MeSH terms

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 treatment time duration from the time diagnosing CT-EXTEM prolongation to the time achieving bleeding control 1 min
Secondary Red Blood Cell amount Red Blood Cell transfusion amount during surgery I hour
Secondary FFP amount Red Blood Cell transfusion amount during surgery 1 hour
Secondary Platelet amount Platelet transfusion amount during surgery 1 hour
Secondary CT-EXTEM clotting time-EXTEM after PCC or FFP 10 min
Secondary MA-EXTEM Maximal amplitude-EXTEM after PCC or FFP 10 min
Secondary MA-FIBTEM Maximal amplitude-FIBTEM after PCC or FFP 10 min
Secondary Postoperative bleeding chest tube drainage at postoperative 24 hour 24 hour
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