Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Bleeding Management During Cardiac Surgery
Official title: Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Cardiac Surgery
Run by Konkuk University Medical Center · NCT06144125 · Data updated 2026-11-12
This trial tests whether prothrombin complex concentrate or fresh frozen plasma works better to stop bleeding during cardiac surgery in patients with valve disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Konkuk University Medical Center Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Status | Recruiting |
| Started | March 27, 2026 |
| Main results expected | September 30, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT06144125 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing cardiac valve surgery without thrombocytopenia, on oral anticoagulants, or receiving anti-platelet agents.
✕Probably not a fit
Patients who have conditions or treatments that affect coagulation beyond the exclusion criteria may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 4 trial compares two blood-clotting products, prothrombin complex concentrate (PCC) and fresh frozen plasma (FFP), when used in a goal-directed approach to control bleeding during cardiac valve surgery. The primary endpoint is how quickly hemostasis is achieved after administration. Participants are adults undergoing cardiac surgery, with exclusions for thrombocytopenia, use of oral anticoagulants, or anti-platelet agents. The study is led by Konkuk University Medical Center with collaboration from Asan Medical Center and Soonchunhyang University Hospital in Seoul, South Korea.
Why it matters
Potential benefit: If successful, the approach could shorten bleeding control time and potentially reduce transfusion needs during cardiac surgery.
How similar studies have gone: Prior studies in similar settings have shown promise for PCC and FFP in bleeding management, but results vary by context and procedure.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients undergoing cardiac surgery Exclusion Criteria: * thrombocytopenia * oral anti-coagulant * anti platelet agents
Where it's running
-
Konkuk University Medical Center
Seoul, Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Tae-Yop Kim, MD PhD — Konkuk University Medical Center
- Study coordinator: Tae-Yop KIm, MD PhD
- Email: taeyop@gmail.com
- Phone: +82-10-8811-6942
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.