Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT03542760
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2018-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acquired Methemoglobinemia Observational Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008708', 'term': 'Methemoglobinemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008751', 'term': 'Methylene Blue'}], 'ancestors': [{'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'targetDuration': '10 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2018-05-20', 'studyFirstSubmitQcDate': '2018-05-20', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prevalence by Agent', 'timeFrame': 'Index Hospitalization', 'description': 'Prevalence of acquired methemoglobinemia cases by suspected causal agent'}, {'measure': 'Resolution of Symptoms', 'timeFrame': 'Index Hospitalization', 'description': 'Resolution of methemoglobinemia-related symptoms during the index hospitalization'}], 'primaryOutcomes': [{'measure': 'Reduction of Methemoglobin 1h after Administration of ProvayBlue', 'timeFrame': '1h post-treatment', 'description': 'Level of methemoglobin 1h after administration of ProvayBlue for treatment of acquired methemoglobinemia compared to pre-treatment level of methemoglobin.'}], 'secondaryOutcomes': [{'measure': 'Time to Normalization of Respiratory Rate', 'timeFrame': 'Index Hospitalization', 'description': 'Time to normalization of respiratory rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.'}, {'measure': 'Time to Normalization of Heart Rate', 'timeFrame': 'Index Hospitalization', 'description': 'Time to normalization of heart rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.'}, {'measure': 'Time to Normalization of Blood Pressure', 'timeFrame': 'Index Hospitalization', 'description': 'Time to normalization of blood pressure after administration of ProvayBlue for treatment of acquired methemoglobinemia.'}, {'measure': 'Prevalence and Nature of Adverse Events', 'timeFrame': 'Within 10 days of Treatment', 'description': 'Prevalence and nature of any adverse events occurring within 10 days of the administration of ProvayBlue'}]}, 'conditionsModule': {'keywords': ['Methylene Blue'], 'conditions': ['Methemoglobinemia, Acquired', 'Methemoglobinemia']}, 'descriptionModule': {'briefSummary': 'This prospective, observational registry aims to collect real-world data regarding the safety and efficacy of ProvayBlue® (methylene blue 0.5%) used according to normal standard of care for the treatment of acquired methemoglobinemia. Methylene blue has been used for decades as a rescue medication for the treatment of methemoglobinemia, a rare and potentially life-threatening condition in which elevated levels of methemoglobin impede the delivery of oxygen from blood to body tissues. However, consistent prospective data about the safety and efficacy of this medication are sparse, simply because of the rarity of the disorder. ProvayBlue® received accelerated FDA approval for treatment of acquired methemoglobinemia in 2016. This large, prospective, multi-center observational registry has been initiated to gain more information on the use of methylene blue in the treatment of acquired methemoglobinemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who present in hospital / urgent care setting diagnosed with acquired methemoglobinemia.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult or pediatric patients diagnosed with acquired methemoglobinemia and receiving treatment with ProvayBlue® (methylene blue 0.5%) as per the treating physician's diagnosis and the acute care facility's standard of care\n* Those acquired methemoglobinemia patients whose diagnosis is aided by measurement of methemoglobin and whose ongoing treatment is guided by re-measurement of methemoglobin \\~1h post-treatment with ProvayBlue® in accordance with the US FDA Label prescribing information\n\nExclusion Criteria:\n\n* Refusal of consent (in those subjects approached for consent where required by local institutional procedures)\n* Treatment of methemoglobinemia with another methylene blue product"}, 'identificationModule': {'nctId': 'NCT03542760', 'acronym': 'metHb', 'briefTitle': 'Acquired Methemoglobinemia Observational Registry', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Quality Foundation'}, 'officialTitle': 'Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)', 'orgStudyIdInfo': {'id': 'HQF-METHB-2018001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Treated Group', 'description': 'Subjects who are administered methylene blue for treatment of acquired methemoglobinemia that is symptomatic (eg, exhibiting sleepiness, cyanosis, dizziness, etc) or with measured methemoglobin levels \\> 30%.', 'interventionNames': ['Drug: Methylene Blue']}, {'label': 'Secondary Treated Group', 'description': 'Subjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms', 'interventionNames': ['Drug: Methylene Blue']}], 'interventions': [{'name': 'Methylene Blue', 'type': 'DRUG', 'description': "Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care", 'armGroupLabels': ['Primary Treated Group', 'Secondary Treated Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Health', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Palmetto General', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Health System', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Partners Healthcare; Brigham and Women's", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'St John Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Regions', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Name Medical Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Methodist', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44501', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Health', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Einstein Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Charles V Pollack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Quality Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Quality Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prove pharm', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}