Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2018-05-31
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Primary Treated Group
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%.
Methylene Blue
Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care
Secondary Treated Group
Subjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms
Methylene Blue
Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care
Interventions
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Methylene Blue
Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Treatment of methemoglobinemia with another methylene blue product
ALL
No
Sponsors
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Prove pharm
INDUSTRY
Hospital Quality Foundation
OTHER
Responsible Party
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Principal Investigators
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Charles V Pollack, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Quality Foundation
Locations
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Cedars Sinai
Los Angeles, California, United States
UC Davis Health
Sacramento, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Palmetto General
Palm Beach Gardens, Florida, United States
Tampa General
Tampa, Florida, United States
IU Health
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Health System
Kansas City, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Partners Healthcare; Brigham and Women's
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
St John Medical Center
Detroit, Michigan, United States
HealthPartners Regions
Saint Paul, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
New York Methodist
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
Mercy Health
Youngstown, Ohio, United States
Oregon Health & Sciences University
Portland, Oregon, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
UT Southwestern
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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HQF-METHB-2018001
Identifier Type: -
Identifier Source: org_study_id
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