Cardiac Valve DiseasePhase 4NCT06144125
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery
A Phase 4 study testing fresh frozen plasma and prothrombin complex concentrate in people with Cardiac Valve Disease, run by Konkuk University Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Valve Disease
- What is being tested?
- fresh frozen plasma and prothrombin complex concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Mar 2026to 30 Oct 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing cardiac surgery
Who cannot join
- thrombocytopenia
- oral anti-coagulant
- anti platelet agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul, Seoul, 05030
Gwnag-Hwa Lee, MD, PhD, +82-2-2030-5114, taeyop@kuh.ac.kr
About this study
Official title: Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Cardiac Surgery
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.
- Conditions
- Cardiac Valve Disease
- Being tested
- fresh frozen plasma, prothrombin complex concentrate
- Keywords
- prothrombin complex concentrate, fresh frozen plasma, coagulation, bleeding, cardiac surgery
- Medical subject headings
- Heart Valve Diseases, Hemophilia B, Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fresh frozen plasmaBiological
transfusion of fresh frozen plasma
prothrombin complex concentrateBiological
prothrombin complex concentrate administration
| Study group | Role | What they receive |
|---|---|---|
| fresh frozen plasma | Active comparator | according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, fresh frozen plasma transfusion (FFP) 10-15 ml/kg is performed Receives: Biological: fresh frozen plasma |
| prothrombin complex concentrate | Experimental | according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) 10-15 IU/kg is administered Receives: Biological: prothrombin complex concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment time
duration from the time of diagnosing CT-EXTEM prolongation (ordering PCC or FFP) to the time achieving bleeding control (completing administration of PCC or FFP)
Measured: 1 min
Secondary outcomes (11)
Red Blood Cell amount
Red Blood Cell transfusion amount during surgery
Measured: I hour
FFP amount
Red Blood Cell transfusion amount during surgery
Measured: 1 hour
Platelet amount
Platelet transfusion amount during surgery
Measured: 1 hour
cryoprecipiate amount
amount of cryoprecipitate transfusion
Measured: 1 hour
CT-EXTEM change
clotting time-EXTEM after PCC or FFP
Measured: 1 min
A5-EXTEM change
clot amplitude at 5 min after clot initiation in EXTEM after PCC or FFP
Measured: 1 min
MCF-EXTEM change
Maximal clot firmness in EXTEM after PCC or FFP
Measured: 1 min
A5-FIBTEM change
clot amplitude at 5 min after clot initiation in FIBTEM after PCC or FFP
Measured: 1 min
Postoperative bleeding
chest tube drainage at postoperative 24 hour
Measured: 24 hour
Preparation time
from the start of cross-matching and thawing of FFP or unpacking of PCC in its storage area to the time of its delivery to patients in the operating room
Measured: 1 min
success rate of the 1st coagulation management
incidence of achieving CT-EXTEM < 80 sec after administering PCC or FFP as coagulation management
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start27 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly divided into two groups (experimental vs control groups).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Soonchunhyang University Hospital
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
- Investigators
- Tae-Yop Kim, MD PhD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144125
- Sponsor's protocol ID
- HC22195220002004
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided