Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT03405402
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2018-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2018-01-12', 'studyFirstSubmitQcDate': '2018-01-19', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Irregular antibodies', 'timeFrame': '1 hour before blood transfusion', 'description': 'Presence/abscence of irregular antibodies'}, {'measure': 'Irregular antibodies', 'timeFrame': 'Between 2 to 4 weeks after blood transfusion', 'description': 'Presence/abscence of irregular antibodies'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': '1 hour before blood transfusion', 'description': 'CRP dosage'}, {'measure': 'Cytokine', 'timeFrame': '1 hour before blood transfusion', 'description': 'Cytokine dosage'}, {'measure': 'Cytokine', 'timeFrame': 'Between 2 to 4 weeks after blood transfusion', 'description': 'Cytokine dosage'}, {'measure': 'Heme oxygenase', 'timeFrame': '1 hour before blood transfusion', 'description': 'Heme oxygenase dosage'}, {'measure': 'Heme oxygenase', 'timeFrame': 'Between 2 to 4 weeks after blood transfusion', 'description': 'Heme oxygenase dosage'}, {'measure': 'Lymphocyte typing', 'timeFrame': '1 hour before blood transfusion', 'description': 'Lymphocyte typing'}, {'measure': 'Lymphocyte typing', 'timeFrame': 'Between 2 to 4 weeks after blood transfusion', 'description': 'Lymphocyte typing'}], 'secondaryOutcomes': [{'measure': 'Sex', 'timeFrame': '1 hour before blood transfusion', 'description': 'Sex'}, {'measure': 'Chronic or acute blood transfusion', 'timeFrame': '1 hour before blood transfusion', 'description': 'Blood transfusions planned at regular intervals of time (chronic transfusions) or performed in reaction to a medical issue (acute transfusion).'}, {'measure': 'Blood transfusion indication', 'timeFrame': '1 hour before blood transfusion', 'description': 'Medical reason explaining the necessity of a blood transfusion'}, {'measure': 'Blood donor ethnicity', 'timeFrame': '1 hour before blood transfusion', 'description': 'Blood donor ethnicity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle cell disease', 'Allo-immunization', 'Blood transfusion'], 'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': 'Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described.\n\nThe main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood.\n\nThe aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization and to try to understand the immunological mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital\n\nExclusion Criteria:\n\nNone"}, 'identificationModule': {'nctId': 'NCT03405402', 'briefTitle': 'Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization', 'orgStudyIdInfo': {'id': 'CHUB-PRO-TRANSFU-DREPANO 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion)', 'interventionNames': ['Procedure: Blood sampling']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Allo-immunization not detected', 'interventionNames': ['Procedure: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'Extra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'HUDERF', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Marie Deleers, Ph Biol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanane EL KENZ', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Blood Bank', 'investigatorFullName': 'Hanane EL KENZ', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}