Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT00906295
Status:
COMPLETED
Last Update Posted:
2011-06-06
First Post:
2009-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-03', 'studyFirstSubmitDate': '2009-05-20', 'studyFirstSubmitQcDate': '2009-05-20', 'lastUpdatePostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go-test (TUG)in seconds.', 'timeFrame': '30 days', 'description': 'Timed Up and Go-test is performed when the patient is able to undertake the test after surgery. This is judged by a physiotherapist. The test measures how long it takes the patient to rise, walk 3 meters, turn around, walk back and sit down again.'}], 'secondaryOutcomes': [{'measure': 'The postoperative day patients can walk ten meters', 'timeFrame': '30 days'}, {'measure': 'Length of stay at hospital', 'timeFrame': '30 days'}, {'measure': 'The day the patient is able to perform Timed Up and Go-test', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemoglobin', 'Ambulation'], 'conditions': ['Anemia', 'Arthroplasty', 'Replacement', 'Hip']}, 'referencesModule': {'references': [{'pmid': '41114449', 'type': 'DERIVED', 'citation': 'Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.'}, {'pmid': '34932836', 'type': 'DERIVED', 'citation': 'Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.'}, {'pmid': '25337035', 'type': 'DERIVED', 'citation': 'Nielsen K, Johansson PI, Dahl B, Wagner M, Frausing B, Borglum J, Jensen K, Sturup J, Hvolris J, Rasmussen LS. Perioperative transfusion threshold and ambulation after hip revision surgery--a randomized trial. BMC Anesthesiol. 2014 Oct 10;14:89. doi: 10.1186/1471-2253-14-89. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://www.rigshospitalet.dk', 'label': 'Official hospital homepage'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Patients undergoing replacement of hip arthroplasty\n* Be legally competent\n* Read and understand Danish\n\nExclusion Criteria:\n\n* Present malignant disease\n* Known heart disease with functionality equivalent to NYHA II or CCS II or worse'}, 'identificationModule': {'nctId': 'NCT00906295', 'briefTitle': 'Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'H-D-2009-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Allowed drop in hemoglobin to 4.5-5.5 mmol/L', 'description': 'Transfusion with red blood cells to level between 4.5-5.5 mmol/L', 'interventionNames': ['Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L']}, {'type': 'EXPERIMENTAL', 'label': 'Allowed drop in hemoglobin to 5.6-6.5 mmol/L', 'description': 'Transfusion with red blood cells to level between 5.6-6.5 mmol/L', 'interventionNames': ['Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L']}], 'interventions': [{'name': 'Allowed drop in hemoglobin to 4.5-5.5 mmol/L', 'type': 'OTHER', 'description': 'Transfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 mmol/L)', 'armGroupLabels': ['Allowed drop in hemoglobin to 4.5-5.5 mmol/L']}, {'name': 'Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L', 'type': 'OTHER', 'description': 'Transfusion with red blood cells to between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L)', 'armGroupLabels': ['Allowed drop in hemoglobin to 5.6-6.5 mmol/L']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2100', 'city': 'Copenhagen', 'state': 'Østerbro', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Kamilla Nielsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'MD Kamilla Nielsen', 'oldOrganization': 'Rigshospitalet'}}}}