Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-02-04 @ 11:01 PM
Study NCT ID:
NCT02200692
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2014-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allergic Transfusion Reactions in Plasma Transfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D065227', 'term': 'Transfusion Reaction'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Samples from patients receiving plasma transfusion and samples from plasma units transfused.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients with Serious and Non-Serious Adverse Events', 'timeFrame': 'Up to 8 weeks after transfusion'}], 'primaryOutcomes': [{'measure': 'Change from baseline in concentration of allergen specific Immunoglobin E antibodies', 'timeFrame': 'Baseline and up to 8 weeks', 'description': 'Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated daily during hospital stay (anticipated up to 14 days), and 4, 6 and/or 8 weeks after transfusion.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in basophil reactivity measured by flow cytometry', 'timeFrame': 'Baseline and up to 8 weeks', 'description': 'Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated during hospital stay, and 4, 6 and/or 8 weeks after transfusion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['plasma transfusion', 'allergic transfusion reaction', 'transfusion reaction', 'blood transfusion', 'Solvent detergent plasma'], 'conditions': ['Allergy', 'Transfusion Reaction']}, 'descriptionModule': {'briefSummary': 'Allergic transfusion reactions are a common complication of transfusion by blood components containing plasma. This study aims to investigate passive transfer of Immunoglobin E antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent Detergent plasma.', 'detailedDescription': 'Prospective observation study, aiming to measure transfer of Immunoglobin E antibodies and other factors associated with allergic complications in patients receiving plasma transfusion. Samples from patients and plasma units will be investigated. Samples frozen until investigation. To assess biological relevance of findings, additional analysis of basophil reactivity will be performed and information on clinical allergy collected by use of a questionaire .\n\nIn-patients will be recruited if receiving plasma transfusion during surgery or if an allergic transfusion complication occurs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving plasma transfusion, mainly in relation to cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving plasma transfusion\n\nExclusion Criteria:\n\n\\- Patients not able to complete sampling procedure'}, 'identificationModule': {'nctId': 'NCT02200692', 'briefTitle': 'Allergic Transfusion Reactions in Plasma Transfusion', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion', 'orgStudyIdInfo': {'id': '2014/607'}, 'secondaryIdInfos': [{'id': 'REK 2014/607', 'type': 'OTHER', 'domain': 'REC West 2014/607'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'plasma transfusion', 'description': 'Patients receiving plasma transfusion.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Torunn O Apelseth, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helse Bergen HF, Haukeland University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}