Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01409967
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2011-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-23', 'studyFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anemia', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anemia', 'Transfusion', 'Biological markers'], 'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'The aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.', 'detailedDescription': 'The aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.\n\nThe patient selection criteria are:\n\n* age \\> or = 18 years\n* No history of transfusion \\> or = 2 years\n* Anemia (any etiology known or assumed)\n* Decision of red packed cells transfusion for the current episode\n* Transfusion performed at BEAUJON Hospital\n* Agreement of patient for the study\n\nNumber of subjects required: 100 patients\n\nStudy duration and duration of participation for each patient:\n\n* duration of the study: 1 year\n* for each patient the participation to the study began at baseline after the decision of transfusion and stopped at the second sample ie at least 72 hours after the transfusion of red blood cells.\n\nThe maximum contribution for one patient is 5 days.\n\nMethodology: It is a prospective non interventional monocentric (BEAUJON Hospital) study. Two blood tests will be performed; one before transfusion and the other from 48 to 72 hours after red packed cells transfusion.\n\nThe following parameters will be measured before and after red packed cells transfusion:\n\nComplete blood count (CBC) with reticulocyte count; complete iron status (ferritin, serum iron, transferrin, transferrin saturation), soluble transferrin receptor; serum and intraerythrocytic folate levels, vitamin B12; lactate dehydrogenase (LDH), bilirubin (total and free), haptoglobin, orosomucoid, direct coombs test; creatinine; CRP.\n\nThe aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Anemic patient with decision of red packed cells transfusion for the current episode.', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Age \\> or = 18 years\n* No history of transfusion \\> or = 2 years\n* Anemia (any etiology known or assumed)\n* Decision of red packed cells transfusion for the current episode\n* Transfusion performed at BEAUJON Hospital\n* Agreement of patient for the study\n\nEXCLUSION CRITERIA:\n\n* Patient who received between the 2 samples, a treatment which can modify the parameters evaluated (iron, vitamin)'}, 'identificationModule': {'nctId': 'NCT01409967', 'acronym': 'BÉA/T', 'briefTitle': 'The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias', 'orgStudyIdInfo': {'id': 'NI 10060'}, 'secondaryIdInfos': [{'id': 'HAO 10048', 'type': 'OTHER', 'domain': 'Management number'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Hopital BEAUJON', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}], 'overallOfficials': [{'name': 'Froissart Antoine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}