Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT03810092
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'romain.decours@ght85.fr', 'phone': '02 51 44 65 72', 'title': 'Romain DECOURS', 'phoneExt': '+33', 'organization': 'CHD VENDEE'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Time lenght is between inclusion and 6 month after baseline', 'eventGroups': [{'id': 'EG000', 'title': 'Intent to Treat Population', 'description': 'Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur', 'otherNumAtRisk': 238, 'deathsNumAtRisk': 238, 'otherNumAffected': 0, 'seriousNumAtRisk': 238, 'deathsNumAffected': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent to Treat Population', 'description': 'Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 days after surgery', 'unitOfMeasure': 'g/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Questionnaire Activities of Daily Living', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent to Treat Population', 'description': 'Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.42', 'groupDescription': 'Relationship between ADL score evolution and hemoglobine rate, in the no transfusion group', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.05', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-1', 'ciUpperLimit': '2.2', 'groupDescription': 'Relationship between ADL score evolution and hemoglobine rate, in the transfusion group', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-fractural and 6 months after surgery', 'description': 'For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points.\n\nA loss of autonomy will be defined by the decrease of one or more points in the ADL.\n\nResult showed here is the difference of ADL score intra patient', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intent to Treat Population', 'description': 'Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}], 'dropWithdraws': [{'type': 'no ground support', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'ADL not done at J0', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'No hemoglobin measure at J5', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intent to Treat Population', 'description': 'Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000', 'lowerLimit': '83', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '181', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '20.9', 'upperLimit': '25.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Missing value'}, {'title': 'Anterior fracture', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospitalisation time', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-19', 'size': 3173267, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-02T08:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2019-01-17', 'resultsFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-02', 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin Rate', 'timeFrame': '5 days after surgery'}, {'measure': 'Questionnaire Activities of Daily Living', 'timeFrame': 'Pre-fractural and 6 months after surgery', 'description': 'For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points.\n\nA loss of autonomy will be defined by the decrease of one or more points in the ADL.\n\nResult showed here is the difference of ADL score intra patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Femoral Fracture']}, 'descriptionModule': {'briefSummary': 'Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study is intended for patients over 75 years of age who have had a fracture of the upper extremity of the femur operated on.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 75 years\n* Patient operated on a fracture of the upper extremity of the femur\n* Patient, family or close relative who does not object to participation in the study\n* Patient affiliated to a social security system\n* Patient who can be monitored as part of the protocol\n\nExclusion Criteria:\n\n* Refusal to participate in the study (patient, family or trusted relative)\n* Patient with support on the operated limb not authorized by the surgeon\n* Patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...)\n* Patient with a pathologic fracture\n* Patient included in Category 1 interventional research (involving a drug or medical device)\n* Patient deprived of liberty\n* Patient not affiliated to a social security system'}, 'identificationModule': {'nctId': 'NCT03810092', 'acronym': 'PAAF', 'briefTitle': 'Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur', 'orgStudyIdInfo': {'id': 'CHD117-17'}}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Cholet', 'country': 'France', 'facility': 'CH Cholet', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Départemental Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'La Rochelle', 'country': 'France', 'facility': 'CH La Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'St-Malo', 'country': 'France', 'facility': 'CH Saint Malo', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}], 'overallOfficials': [{'name': 'Romain DECOURS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHD Vendée'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}