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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06144125
- Acronym / sponsor ID
- HC22195220002004
- Conditions
- Cardiac Valve Disease
- Keywords
- prothrombin complex concentrate, fresh frozen plasma, coagulation, bleeding, cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- Asan Medical Center, Soonchunhyang University Hospital
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomly divided into two groups (experimental vs control groups).
| Arm | Type | Receives |
|---|---|---|
| fresh frozen plasma | Active comparator | Biological: fresh frozen plasmaaccording to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, fresh frozen plasma transfusion (FFP) 10-15 ml/kg is performed |
| prothrombin complex concentrate | Experimental | Biological: prothrombin complex concentrateaccording to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) 10-15 IU/kg is administered |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing cardiac surgery
Key exclusion criteria (3 listed)
- thrombocytopenia
- oral anti-coagulant
- anti platelet agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fresh frozen plasmatransfusion of fresh frozen plasma | Biological | fresh frozen plasma |
| prothrombin complex concentrateprothrombin complex concentrate administration | Biological | prothrombin complex concentrate |
Primary outcome
treatment time
Time frame: 1 min
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)
11 secondary outcomes
Red Blood Cell amount
Time frame: I hour
FFP amount
Time frame: 1 hour
Platelet amount
Time frame: 1 hour
cryoprecipiate amount
Time frame: 1 hour
CT-EXTEM change
Time frame: 1 min
A5-EXTEM change
Time frame: 1 min
MCF-EXTEM change
Time frame: 1 min
A5-FIBTEM change
Time frame: 1 min
Postoperative bleeding
Time frame: 24 hour
Preparation time
Time frame: 1 min
success rate of the 1st coagulation management
Time frame: 10 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tae-Yop Kim, MD PhD principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tae-Yop KIm, MD PhD (+82-10-8811-6942, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment time (time frame: 1 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.