Association Between Post-operative Anemia and Mortality After Valvular Heart Surgery

October 16, 2024 updated by: Yonsei University

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine and Anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

tertiary care hospital

Description

Inclusion Criteria:

  • Patients who underwent valvular heart surgery between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
preoperative anemia-postoperative anemia
preopertive anemia-postoperitve non-anemia
preoperative non-anemia-postoperative anemia
preopeartive non-anemia-postopertive non-anemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year after valvular heart surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall mortality
Time Frame: postopeartive one-year
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.
postopeartive one-year
composite of death and congestive heart failure (CHF) requiring rehospitalization
Time Frame: postopeartive one-year
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.
postopeartive one-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Estimated)

July 21, 2025

Study Completion (Estimated)

July 21, 2025

Study Registration Dates

First Submitted

October 13, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2024-0674

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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