Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-28 @ 1:58 AM
Study NCT ID:
NCT07094295
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Blood Transfusion and Increased One-year Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97443}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'one-year mortality after surgery', 'timeFrame': 'one year after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mortality, Perioperative Blood Transfusion, Propensity Score, Retrospective Study, Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this retrospective observational study is to explore the association of perioperative blood transfusion with increased one-year mortality in patients undergoing surgeries. The main question it aims to answer perioperative blood transfusion is associated with increased one-year mortality across various surgical settings. We will retrospectively collect the clinical data (including one-year mortality) in patients with perioperative blood transfusion or not and analysis the association between perioperative blood transfusion and one-year mortality after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who underwent surgery at Singapore General Hospital between 1 January 2012 and 31 October 2016', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years\n* Patients undergoing first-time cardiothoracic surgery, orthopedics, obstetrics and gynecology, general surgery, otolaryngology, hand surgery, neurosurgery, colorectal surgery, urology, plastic surgery, and oral and maxillofacial surgery were included.\n\nExclusion Criteria:\n\n* Patients with missing values for the American Society of Anesthesiologists (ASA) physical status, revised cardiac risk index (RCRI), degree of preoperative anemia, kidney disease, or race were excluded.'}, 'identificationModule': {'nctId': 'NCT07094295', 'briefTitle': 'Perioperative Blood Transfusion and Increased One-year Mortality', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Association of Perioperative Blood Transfusion With Increased One-year Mortality After Surgery: a Retrospective Propensity Score-Matched Cohort Study', 'orgStudyIdInfo': {'id': 'PBTOM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PBT group', 'description': 'Patients in PBT group received red blood cell concentrate units during surgery and up to one month postoperatively.', 'interventionNames': ['Other: perioperative blood transfusion']}, {'label': 'No-PBT group', 'description': 'Patients in No-PBT group did not receive red blood cell concentrate units during surgery and up to one month postoperatively.'}], 'interventions': [{'name': 'perioperative blood transfusion', 'type': 'OTHER', 'description': 'The PBT group received the red blood cell concentrate units during surgery and up to one month postoperatively.', 'armGroupLabels': ['PBT group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wen-bin Lu, MD', 'investigatorAffiliation': 'Changhai Hospital'}}}}