Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-30 @ 12:43 AM
Study NCT ID:
NCT05742035
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006432', 'term': 'Hemochromatosis'}, {'id': 'D000085583', 'term': 'Hyperferritinemia'}], 'ancestors': [{'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D019190', 'term': 'Iron Overload'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018962', 'term': 'Phlebotomy'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'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': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Assessors of quality parameters don't know the diagnosis of the included participants"}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective inclusion of individual and group allocation according to the collected clinical data and diagnoses.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemolysis rate vs regulatory standards.', 'timeFrame': 'After 42 days of storage', 'description': 'To verify that the hemolysis rate in % at the end of storage (day 42) of RBC from individuals with elevated ferritin is within the current accepted European standard of 0.8%.'}], 'secondaryOutcomes': [{'measure': 'Hemolysis hyperferritinemia vs controls end of storage.', 'timeFrame': 'After 42 days of storage', 'description': 'Comparison of haemolysis rate in % at day 42 in RBC from individuals with elevated ferritin of any cause and those with normal ferritin levels.'}, {'measure': 'Hemolysis hereditary hemochromatosis (HH) vs secondary hyperferritinemia entd of storage.', 'timeFrame': 'After 42 days of storage', 'description': 'Comparisons of hemolysis rate in % at day 42 in RBC from individuals with HH and those with secondary hyperferritinemia.'}, {'measure': 'Hemolysis hyperferritinemia vs controls day 1.', 'timeFrame': 'After 42 days of storage', 'description': 'Comparisons of hemolysis rate in % at day 1 in RBC from individuals with hyperferritinemia and those with normal ferritin.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hereditary Hemochromatosis', 'Hyperferritinemia']}, 'descriptionModule': {'briefSummary': 'Iron overload in hereditary hemochromatosis (HH) is treated by phlebotomy. It is unclear, if individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes are suitable as blood donors. The study investigates hemolysis and several other quality parameters of red blood cell concentrates (RBC) obtained from 80 individual with ferritin \\>500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control.', 'detailedDescription': 'Iron overload in hereditary hemochromatosis is treated by phlebotomy. In Switzerland and in many other coutries, these individuals are not accepted for blood donation until ferritin values and phlebotomy intervals are in the normal range.\n\nIndividual with secondary hyperferritinemia, e. g. related to metabolic syndrome, are accepted as blood donors according to their clinical situation.\n\nIt is unclear if the quality of blood products issued from individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes is comparable with the quality of those issued from healthy blood donors, and if their characteristics comply with the international standards.\n\nThe study investigates the hemolysis rate and several other quality parameters in RBC obtained from 80 individual with ferritin \\>500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control. For this purpose, whole blood donations are manufactured according to the standard processes applied in the blood bank. Several standard quality parameters as well as biologic, rheologic, and oxydative stress-related variables are measured and compared, both with the current regulations and with those of the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age:18-75 years\n* Body weight \\> 50 Kg\n* Haemoglobin ≥ 135 g/l (males), ≥ 125 g/l (females)\n* In subjects of the HH and non-HH group: ferritin values \\>500 ng/ml, which must have been measured in the last three months before the inclusion in the study (either at the Blood Donation service or elsewhere), not followed by a blood donation or a phlebotomy\n* In subjects of the HH group: genetic test demonstrating the presence of p.C282Y homozygous or p.C282Y/p.H63D compound heterozygous HFE-gene mutation\n* In subjects of the control group: ferritin values \\< 300 ng/ml (males) or \\< 200 ng/ml (females)\n* Written informed consent to the participation in the study\n\nExclusion Criteria:\n\n* Inadequate vein access for whole blood collection\n* Body weight \\< 50 kg\n* Chronic viral infection (hepatitis B or C, HIV)\n* Previous acute coronary heart disease\n* Previous or current history of epilepsy\n* Other severe conditions that could significantly increase the phlebotomy risk, based on individual medical evaluation\n* No informed consent\n* Pregnancy (according to the information on the standard blood donor questionnaire)'}, 'identificationModule': {'nctId': 'NCT05742035', 'briefTitle': 'Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.', 'organization': {'class': 'OTHER', 'fullName': 'Interregionale Blutspende SRK'}, 'officialTitle': 'Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.', 'orgStudyIdInfo': {'id': '2022-00274'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hereditary hemochromatosis', 'description': 'Individual with ferritin \\>500 ng/mL and documented homozygous or compound heterozygous HFE-gen mutation.', 'interventionNames': ['Procedure: Venipuncture']}, {'type': 'EXPERIMENTAL', 'label': 'secondary hyperferritinemia', 'description': 'Individual with ferritin \\>500 ng/mL, not fulfilling the criteria for hereditary hemochromatosis.', 'interventionNames': ['Procedure: Venipuncture']}, {'type': 'OTHER', 'label': 'healthy blood donor with normal ferritin value.', 'description': 'Healthy comparator.', 'interventionNames': ['Procedure: Venipuncture']}], 'interventions': [{'name': 'Venipuncture', 'type': 'PROCEDURE', 'description': 'Bloodletting of 450 mL, followed by separation of the whole blood in 2 blood components: 1 red blood cell concentrate and 1 plasma. Measurement of the outcomes in the red blood cell concentrate.', 'armGroupLabels': ['Hereditary hemochromatosis', 'healthy blood donor with normal ferritin value.', 'secondary hyperferritinemia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'Blutspendedienst SRK beider Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3008', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Interregionale Blutspende SRK', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Interregionale Blutspende SRK', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Medical Department, Principal Investigator', 'investigatorFullName': 'Stefano Fontana', 'investigatorAffiliation': 'Interregionale Blutspende SRK'}}}}