Cardiac Valve DiseaseNCT04031144
Ultrafiltration on Coagulation Function in Cardiac Surgery
A study testing Ultrafiltration in people with Cardiac Valve Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
To determine the effect of modified ultrafiltration, which is usually employed for reducing free water at the end of cardiopulmonary bypass (CPB), on coagulation profile in patients undergoing cardiac surgery Read more about this study
- Who is it for?
- Ages 19 months to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Valve Disease
- What is being tested?
- Ultrafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2020to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 months to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB)
- maximal clot formation (MCF) in ROTEM-EXTEM is reduced (< 50.5 mm before applying ultrafiltration)
Who cannot join
- transfusion of packed RBC> 3 units during CPB
- total ultrafiltration volume < 250 ml
- hyperfibrinolysis (lysis% > 10%) before applying ultrafiltration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultrafiltration Before Weaning From Cardiopulmonary Bypass on Post-bypass Coagulation Function in Cardiac Surgery
To determine the effect of modified ultrafiltration, which is usually employed for reducing free water at the end of cardiopulmonary bypass (CPB), on coagulation profile in patients undergoing cardiac surgery
- Conditions
- Cardiac Valve Disease
- Being tested
- Ultrafiltration
- Keywords
- coagulation, ultrafiltration, cardiac surgery
- Medical subject headings
- Heart Valve Diseases, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrafiltrationProcedure or surgery
At the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components.
| Study group | Role | What they receive |
|---|---|---|
| Ultrafiltration | Experimental | Ultrafiltration is applied at the end of cardiopulmonary bypass. Maximal clot formation (MCF) of ROTEM-EXTEM tracing is reduced before applying the ultrafiltration. Receives: Procedure: Ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay
change of MCF in EXTEM assay before and after applying ultrafiltration
Measured: 5 min-before and 5 min-after applying ultrafiltration
Secondary outcomes (4)
Change of Clotting time (CT) in rotational thromboelastometry, EXTEM assay
change of CT in EXTEM assay before and after applying ultrafiltration
Measured: 5 min-before and 5 min-after applying ultrafiltration
Change of Maximal clot formation at 5 min (A5) in rotational thromboelastometry, FIBTEM assay
change of A5 in FIBTEM assay before and after applying ultrafiltration
Measured: 5 min-before and 5 min-after applying ultrafiltration
Change of Percent of lysis (lysis%) in rotational thromboelastometry, EXTEM assay
change of lysis% before and after applying ultrafiltration
Measured: 5 min-before and 5 min-after applying ultrafiltration
Hematocrit (Hct) change
change of Hct before and after applying ultrafiltration
Measured: 5 min-before and 5 min-after applying ultrafiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start30 Jan 2020
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with reduced clot strength before applying ultrafiltration (patients with MCF in ROTEM-EXTEM less than the cut-off value, determined by preliminary analyses, n=30). ROC analysis of the preliminary data was performed, and the cut-off value was 50.5 mm. The sample size of the present study is determined by using these data. The minimum sample size to detect the observed difference after applying ultrafiltration was 26. Considering 50% possible loss, 39 patients will be recruited for the primary analysis. Patients scheduled for elective cardiac surgery with cardiopulmonary bypass are recruited first, and the data from patients with MCF \<50.5 mm will be included in the final analysis.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031144
- Sponsor's protocol ID
- KUMC 2019-05-008
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2019
- Last updated
- 12 Sep 2025
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrafiltration Before Weaning From Cardiopulmonary Bypass on Post-bypass Coagulation Function in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04031144
- Acronym / sponsor ID
- KUMC 2019-05-008
- Conditions
- Cardiac Valve Disease
- Keywords
- coagulation, ultrafiltration, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 24 Jul 2019 (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.
To determine the effect of modified ultrafiltration, which is usually employed for reducing free water at the end of cardiopulmonary bypass (CPB), on coagulation profile in patients undergoing cardiac surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with reduced clot strength before applying ultrafiltration (patients with MCF in ROTEM-EXTEM less than the cut-off value, determined by preliminary analyses, n=30). ROC analysis of the preliminary data was performed, and the cut-off value was 50.5 mm. The sample size of the present study is determined by using these data. The minimum sample size to detect the observed difference after applying ultrafiltration was 26. Considering 50% possible loss, 39 patients will be recruited for the primary analysis. Patients scheduled for elective cardiac surgery with cardiopulmonary bypass are recruited first, and the data from patients with MCF <50.5 mm will be included in the final analysis.
| Arm | Type | Receives |
|---|---|---|
| Ultrafiltration | Experimental | Procedure: UltrafiltrationUltrafiltration is applied at the end of cardiopulmonary bypass. Maximal clot formation (MCF) of ROTEM-EXTEM tracing is reduced before applying the ultrafiltration. |
Who may qualify
- Ages
- 19 months to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB)
- maximal clot formation (MCF) in ROTEM-EXTEM is reduced (< 50.5 mm before applying ultrafiltration)
Key exclusion criteria (3 listed)
- transfusion of packed RBC> 3 units during CPB
- total ultrafiltration volume < 250 ml
- hyperfibrinolysis (lysis% > 10%) before applying ultrafiltration
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 |
|---|---|---|
| UltrafiltrationAt the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components. | Procedure or surgery | Ultrafiltration |
Primary outcome
Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay
Time frame: 5 min-before and 5 min-after applying ultrafiltration
change of MCF in EXTEM assay before and after applying ultrafiltration
4 secondary outcomes
Change of Clotting time (CT) in rotational thromboelastometry, EXTEM assay
Time frame: 5 min-before and 5 min-after applying ultrafiltration
Change of Maximal clot formation at 5 min (A5) in rotational thromboelastometry, FIBTEM assay
Time frame: 5 min-before and 5 min-after applying ultrafiltration
Change of Percent of lysis (lysis%) in rotational thromboelastometry, EXTEM assay
Time frame: 5 min-before and 5 min-after applying ultrafiltration
Hematocrit (Hct) change
Time frame: 5 min-before and 5 min-after applying ultrafiltration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrafiltration 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 2 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: finished, as of the sponsor's last update on 12 Sep 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay (time frame: 5 min-before and 5 min-after applying ultrafiltration). 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 12 Sep 2025.