Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-19 @ 7:49 PM
Study NCT ID:
NCT06647758
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-18
First Post:
2024-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Post-operative Anemia and Mortality After Valvular Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-07-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-10-13', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative 1-year mortality', 'timeFrame': 'One year after valvular heart surgery', 'description': 'The investigators assessed all-cause mortality during one year after valvular heart surgery and evaluated its association with preoperative and postoperative anemic status.'}], 'secondaryOutcomes': [{'measure': 'overall mortality', 'timeFrame': 'postopeartive one-year', 'description': '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.'}, {'measure': 'composite of death and congestive heart failure (CHF) requiring rehospitalization', 'timeFrame': 'postopeartive one-year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Undergoing Valvular Heart Surgery']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'tertiary care hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent valvular heart surgery between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System.\n\nExclusion Criteria:\n\n* patients who underwent only pulmonary valve surgery\n* those with missing hemoglobin values at 2months after the surgery, due to loss of follow up or death.'}, 'identificationModule': {'nctId': 'NCT06647758', 'briefTitle': 'Association Between Post-operative Anemia and Mortality After Valvular Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Association Between Remote Post-operative Anemia and Mortality in Patients Undergoing Valvular Heart Surgery', 'orgStudyIdInfo': {'id': '4-2024-0674'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'preoperative anemia-postoperative anemia'}, {'label': 'preopertive anemia-postoperitve non-anemia'}, {'label': 'preoperative non-anemia-postoperative anemia'}, {'label': 'preopeartive non-anemia-postopertive non-anemia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine and Anesthesia', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}