Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2026-01-03 @ 5:56 PM
Study NCT ID:
NCT05399693
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2022-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Transfusion Refractoriness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017713', 'term': 'Platelet Transfusion'}], 'ancestors': [{'id': 'D016913', 'term': 'Blood Component Transfusion'}, {'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-11-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2022-05-25', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Research of predictive criteria of Platelet transfusion refractoriness', 'timeFrame': 'blood samples before the transfusion of each chemotherapy cycle', 'description': 'Characterisation of anti-HLA I antibodies (recognised epitopes and isotypes) associated to Platelet transfusion refractoriness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Platelet Transfusion Refractoriness']}, 'descriptionModule': {'briefSummary': 'Platelet Transfusion Refractoriness is one of the severe complications after multiple transfusions in patients with severe thrombopenia. Platelet Transfusion Refractoriness is characterized by inefficient transfusion and arise from allo-antibodies specific of platelets antigenes, mostly carried by HLA-I molecules.', 'detailedDescription': 'A preliminary study has shown different isotypes of anti-HLA I in patients with Platelet Transfusion Refractoriness. Our hypothesis is that the type of anti-HLA I antibodies (recognised epitope, quantity, isotype) should establish predictive and diagnostic criteria for Platelet Transfusion Refractoriness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient :\n\n* with Hematopoietic stem cells graft (autograft or allograft)\n* or with acute leukemia with the indication of platelet transfusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient with Hematopoietic stem cells graft (autograft or allograft) or with acute leukemia with the indication of platelet transfusion.\n\nExclusion Criteria:\n\n* Patient under guardianship\n* Minor patient'}, 'identificationModule': {'nctId': 'NCT05399693', 'acronym': 'ACERTP', 'briefTitle': 'Platelet Transfusion Refractoriness', 'organization': {'class': 'OTHER', 'fullName': 'Institut de cancérologie Strasbourg Europe'}, 'officialTitle': 'Characterization of Anti-HLA I Antibodies Involved in Platelet Transfusion Refractoriness: Optimization of the Transfusion Management of Patients With Severe Thrombocytopenia', 'orgStudyIdInfo': {'id': '2021-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Platelet Transfusion Refractoriness', 'interventionNames': ['Procedure: platelet transfusion']}, {'label': 'Patients without Platelet Transfusion Refractoriness', 'interventionNames': ['Procedure: platelet transfusion']}], 'interventions': [{'name': 'platelet transfusion', 'type': 'PROCEDURE', 'description': 'platelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia', 'armGroupLabels': ['Patients with Platelet Transfusion Refractoriness', 'Patients without Platelet Transfusion Refractoriness']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Manon VOEGELIN', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu'}, {'name': 'Luc FORNECKER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de cancérologie Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Manon VOEGELIN', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '03 68 33 95 23'}, {'name': 'Claire VIT', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '03 68 33 95 23'}], 'overallOfficials': [{'name': 'Luc FORNECKER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de cancérologie Strasbourg Europe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de cancérologie Strasbourg Europe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}