Patients Undergoing Valvular Heart SurgeryNCT06647758
Association Between Post-operative Anemia and Mortality After Valvular Heart Surgery
An observational study of Patients Undergoing Valvular Heart Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators aimed to evaluate whether postoperative anemia can predict 1-year mortality after valvular heart surgery independent of preoperative anemia. Patients who underwent valvular heart surgery were divided into four groups according to whether or not they had preoperative and postoperative anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Valvular Heart Surgery
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jul 2024to 21 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tertiary care hospital
Who may be able to join
- Patients who underwent valvular heart surgery between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System.
Who cannot join
- patients who underwent only pulmonary valve surgery
- those with missing hemoglobin values at 2months after the surgery, due to loss of follow up or death.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia
Seoul, 120-752
About this study
Official title: Association Between Remote Post-operative Anemia and Mortality in Patients Undergoing Valvular Heart Surgery
The investigators aimed to evaluate whether postoperative anemia can predict 1-year mortality after valvular heart surgery independent of preoperative anemia. Patients who underwent valvular heart surgery were divided into four groups according to whether or not they had preoperative and postoperative anemia. Postoperative one-year mortality, as well as overall mortality and a composite of death and heart failure requiring hospitalization, was investigated according to the groups, adjusted by confounders.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preoperative anemia-postoperative anemia | Not described | |
| preopertive anemia-postoperitve non-anemia | Not described | |
| preoperative non-anemia-postoperative anemia | Not described | |
| preopeartive non-anemia-postopertive non-anemia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative 1-year mortality
The investigators assessed all-cause mortality during one year after valvular heart surgery and evaluated its association with preoperative and postoperative anemic status.
Measured: One year after valvular heart surgery
Secondary outcomes (2)
overall mortality
The investigators assessed overall mortality during the follow-up period and a composite of death and congestive heart failure (CHF) requiring rehospitalization during the postoperative one-year and evaluated their associations with preoperative and postoperative anemic status.
Measured: postopeartive one-year
composite of death and congestive heart failure (CHF) requiring rehospitalization
The investigators assessed overall mortality during the follow-up period and a composite of death and congestive heart failure (CHF) requiring rehospitalization during the postoperative one-year and evaluated their associations with preoperative and postoperative anemic status.
Measured: postopeartive one-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start22 Jul 2024
- Primary completion21 Jul 2025 (estimated)
- Study completion21 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Valvular Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647758
- Sponsor's protocol ID
- 4-2024-0674
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Remote Post-operative Anemia and Mortality in Patients Undergoing Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT06647758
- Acronym / sponsor ID
- 4-2024-0674
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 21 Jul 2025 (estimated)
- Study completion
- 21 Jul 2025 (estimated)
- First posted
- 18 Oct 2024 (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 investigators aimed to evaluate whether postoperative anemia can predict 1-year mortality after valvular heart surgery independent of preoperative anemia. Patients who underwent valvular heart surgery were divided into four groups according to whether or not they had preoperative and postoperative anemia. Postoperative one-year mortality, as well as overall mortality and a composite of death and heart failure requiring hospitalization, was investigated according to the groups, adjusted by confounders.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| preoperative anemia-postoperative anemia | – | – |
| preopertive anemia-postoperitve non-anemia | – | – |
| preoperative non-anemia-postoperative anemia | – | – |
| preopeartive non-anemia-postopertive non-anemia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care hospital
Key inclusion criteria (1 listed)
- Patients who underwent valvular heart surgery between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System.
Key exclusion criteria (2 listed)
- patients who underwent only pulmonary valve surgery
- those with missing hemoglobin values at 2months after the surgery, due to loss of follow up or death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative 1-year mortality
Time frame: One year after valvular heart surgery
The investigators assessed all-cause mortality during one year after valvular heart surgery and evaluated its association with preoperative and postoperative anemic status.
2 secondary outcomes
overall mortality
Time frame: postopeartive one-year
composite of death and congestive heart failure (CHF) requiring rehospitalization
Time frame: postopeartive one-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- 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 Patients Undergoing Valvular Heart Surgery, run by Yonsei University 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 2 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: status not confirmed, as of the sponsor's last update on 18 Oct 2024. 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?
Results are not available in the source record.
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?
postoperative 1-year mortality (time frame: One year after valvular heart surgery). 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 18 Oct 2024.