Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT04035902
Status:
UNKNOWN
Last Update Posted:
2020-08-19
First Post:
2019-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative IV Iron on Postoperative Red Blood Cell Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2019-07-21', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative hematocrit (%)', 'timeFrame': '7 days after surgery', 'description': 'hematocrit is evaluated on postoperative 7 days'}], 'secondaryOutcomes': [{'measure': 'volume of post-operative bleeding (ml)', 'timeFrame': '7 day', 'description': 'total volume of postoperative bleeding collected in the drainage container (hemovac)'}, {'measure': 'intraoperative blood transfusion (ml)', 'timeFrame': '1 day', 'description': 'total volume of intraoperative blood transfusion'}, {'measure': 'post-operative blood transfusion (ml)', 'timeFrame': '7 days', 'description': 'total amount of post-operative blood transfusion (ml)'}, {'measure': 'post-operative serum ferritin level (ng/ml)', 'timeFrame': '1 day', 'description': 'post-operative serum ferritin level (ng/ml) is checked immediately after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iron', 'arthroplasty', 'red blood cell'], 'conditions': ['Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': 'The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative recovery of RBC mass by retrospectively analyzing and comparing the changes of postoperative hematocrit values after the surgery in patients underwent elective uni-limb total knee arthroplasty surgery with or without IV-iron supplementation during surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery\n* Patients provided a written informed consent.\n* Patients with s-ferritin \\< 300 mg/dl (male) or 200 mg/dl (female)\n* Patients with preoperative serum hemoglobin concentration \\>10 g/dL\n\nExclusion criteria\n\n* Patients with history of anaphylaxis, iron overload, active infection.\n* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.'}, 'identificationModule': {'nctId': 'NCT04035902', 'briefTitle': 'Intraoperative IV Iron on Postoperative Red Blood Cell Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Intraoperative IV Iron on the Postoperative Recovery of Red Blood Cell in Hip Arthroplasty Surgery', 'orgStudyIdInfo': {'id': 'KUH 2019-05-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ferric carboxymaltose 1000 mg', 'description': 'Ferric carboxymaltose is administered during surgery', 'interventionNames': ['Drug: Ferric carboxymaltose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'Ferric carboxymaltose is not administered', 'interventionNames': ['Drug: control']}], 'interventions': [{'name': 'Ferric carboxymaltose', 'type': 'DRUG', 'description': 'Ferric carboxymaltose is administered during surgery', 'armGroupLabels': ['ferric carboxymaltose 1000 mg']}, {'name': 'control', 'type': 'DRUG', 'description': 'Ferric carboxymaltose is not administered', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tae-Yop Kim, MD PhD', 'role': 'CONTACT', 'email': 'taeyop@gmail.com', 'phone': '0220305445'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Anesthesiology', 'investigatorFullName': 'Tae-Yop Kim, MD PhD', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}