Cardiac Valve DiseaseNCT05252559
Ultrafiltration on Coagulation Performance in Cardiac Surgery
An observational study of Cardiac Valve Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
In cardiac surgery patients with CPB-induced dilutional coagulopathy, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components before the weaning from CPB. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Valve Disease
- What is being tested?
- ultrafiltration and maximal clot firmness in EXTEM assay of ROTEM test
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 1 Jun 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients underwent elective cardiac valve surgery with moderate hypothermic CPB and ultrafiltration
Who may be able to join
- Patients underwent cardiac surgery during Jan 2019-Dec 2021
- Patients underwent moderate hypothermic CPB
- Patients underwent ultrafiltration during CPB
- Patients underwent ROTEM tests (EXTEM assays and FIBTEM assay) before and after applying ultrafiltration
Who cannot join
- Patients underwent packed RBC transfusion > 3 units during CPB
- patients underwent ultrafiltration but the removed free water was < 250 ml
- Patients underwent deep hypothermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Modified Ultrafiltration on Whole Blood Coagulation in Cardiac Surgery With Cardiopulmonary Bypass: Retrospective Analysis
In cardiac surgery patients with CPB-induced dilutional coagulopathy, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components before the weaning from CPB. The impact of UF on the clot strength is determined by analyzing the changes of maximal clot formation in EXTEM assay (MCF-EXTEM) in the ROTEM test in patients who underwent elective cardiac valve surgery in KUMC.
Read the detailed description
In cardiac surgery patients, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components during cardiopulmonary bypass (CPB). Concentrating plasma substrate of UF would be beneficial in attenuating CPB-induced dilutional coagulopathy. This study was to investigate whether MUF affected viscoelastic profiles during CPB for cardiac surgery.
Patients who underwent elective cardiac surgery and MUF at the end of CPB during January 2019-December 2021 are recruited. Using the patients' electronic medical records, the values of maximum clot firmness of EXTEM assay (MCF-EXTEM) of rotational thromboelastometry (ROTEM) test before and after applying MUF are retrospectively analyzed.
As the primary measure, we determine the changes of MCF-EXTEM after applying MUF. With an assumption that MUF increased MCF-EXTEM, the receiver operating characteristic (ROC) analysis is applied to MCF-EXTEM change. The area under the ROC curve is determined and the cut-off value is estimated with specificity and sensitivity in Youden's J statistics. The change of MCF-EXTEM in patients who show MCF-EXTEM less than the cut-off value is analyzed. The changes of hematocrit (Hct) before and after applying MUF is also determined.
- Conditions
- Cardiac Valve Disease
- Being tested
- ultrafiltration, maximal clot firmness in EXTEM assay of ROTEM test
- Keywords
- ultrafiltration, cardiac valve disease, viscoelastic test, cardiopulmonary bypass
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrafiltrationProcedure or surgery
In cardiac surgery patients, ultrafiltration is usually applied to reduce free water and concentrate all blood components before weaning from cardiopulmonary bypass
maximal clot firmness in EXTEM assay of ROTEM testDiagnostic test
before and after applying ultrafiltration, arterial blood sample underwent EXTEM and FIBTEM assays of rotational thromboelastometry
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal clot firmness (MCF) of EXTEM assay
change of MCF-EXTEM assay
Measured: 30 minute after the completion of ultrafiltration
Secondary outcomes (3)
cut-off value of MCF-EXTEM to be improved by ultrafiltration
To estimate the cut-off value of MCF-EXTEM which can be increased by applying ultrafiltration
Measured: 30 minute after the completion of ultrafiltration
maximal clot firmness (MCF) of EXTEM assay to be improved by ultrafiltration
change of MCF-EXTEM by applying ultrafiltration in patients with reduced MCF-EXTEM before applying ultrafiltration (MCF-EXTEM < the estimated cut-off value)
Measured: 30 minute after the completion of ultrafiltration
maximal clot firmness (MCF) of EXTEM assay not to be improved by ultrafiltration
change of MCF-EXTEM by applying ultrafiltration in patients with reduced MCF-EXTEM before applying ultrafiltration (MCF-EXTEM > the estimated cut-off value)
Measured: 30 minute after the completion of ultrafiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Aug 2021
- Primary completion1 May 2022
- Study completion1 Jun 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 75 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
- NCT05252559
- Sponsor's protocol ID
- 2019-05-008
- Status last verified
- Jun 2022
- First submitted
- 25 Jan 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Ultrafiltration on Whole Blood Coagulation in Cardiac Surgery With Cardiopulmonary Bypass: Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05252559
- Acronym / sponsor ID
- 2019-05-008
- Conditions
- Cardiac Valve Disease
- Keywords
- ultrafiltration, cardiac valve disease, viscoelastic test, cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 23 Feb 2022 (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.
In cardiac surgery patients with CPB-induced dilutional coagulopathy, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components before the weaning from CPB. The impact of UF on the clot strength is determined by analyzing the changes of maximal clot formation in EXTEM assay (MCF-EXTEM) in the ROTEM test in patients who underwent elective cardiac valve surgery in KUMC.
Detailed description
In cardiac surgery patients, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components during cardiopulmonary bypass (CPB). Concentrating plasma substrate of UF would be beneficial in attenuating CPB-induced dilutional coagulopathy. This study was to investigate whether MUF affected viscoelastic profiles during CPB for cardiac surgery.
Patients who underwent elective cardiac surgery and MUF at the end of CPB during January 2019-December 2021 are recruited. Using the patients' electronic medical records, the values of maximum clot firmness of EXTEM assay (MCF-EXTEM) of rotational thromboelastometry (ROTEM) test before and after applying MUF are retrospectively analyzed.
As the primary measure, we determine the changes of MCF-EXTEM after applying MUF. With an assumption that MUF increased MCF-EXTEM, the receiver operating characteristic (ROC) analysis is applied to MCF-EXTEM change. The area under the ROC curve is determined and the cut-off value is estimated with specificity and sensitivity in Youden's J statistics. The change of MCF-EXTEM in patients who show MCF-EXTEM less than the cut-off value is analyzed. The changes of hematocrit (Hct) before and after applying MUF is also determined.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients underwent elective cardiac valve surgery with moderate hypothermic CPB and ultrafiltration
Key inclusion criteria (4 listed)
- Patients underwent cardiac surgery during Jan 2019-Dec 2021
- Patients underwent moderate hypothermic CPB
- Patients underwent ultrafiltration during CPB
- Patients underwent ROTEM tests (EXTEM assays and FIBTEM assay) before and after applying ultrafiltration
Key exclusion criteria (3 listed)
- Patients underwent packed RBC transfusion > 3 units during CPB
- patients underwent ultrafiltration but the removed free water was < 250 ml
- Patients underwent deep hypothermia
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 |
|---|---|---|
| ultrafiltrationIn cardiac surgery patients, ultrafiltration is usually applied to reduce free water and concentrate all blood components before weaning from cardiopulmonary bypass | Procedure or surgery | – |
| maximal clot firmness in EXTEM assay of ROTEM testbefore and after applying ultrafiltration, arterial blood sample underwent EXTEM and FIBTEM assays of rotational thromboelastometry | Diagnostic test | – |
Primary outcome
maximal clot firmness (MCF) of EXTEM assay
Time frame: 30 minute after the completion of ultrafiltration
change of MCF-EXTEM assay
3 secondary outcomes
cut-off value of MCF-EXTEM to be improved by ultrafiltration
Time frame: 30 minute after the completion of ultrafiltration
maximal clot firmness (MCF) of EXTEM assay to be improved by ultrafiltration
Time frame: 30 minute after the completion of ultrafiltration
maximal clot firmness (MCF) of EXTEM assay not to be improved by ultrafiltration
Time frame: 30 minute after the completion of 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 10 Jun 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of 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 4 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 10 Jun 2022. 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?
maximal clot firmness (MCF) of EXTEM assay (time frame: 30 minute after the completion of 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 10 Jun 2022.