Acquired Methemoglobinemia Observational Registry

Completed

Conditions studied: Methemoglobinemia, Acquired, Methemoglobinemia

In brief

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.

Key facts

Study ID

NCT03542760

Run by

Hospital Quality Foundation

People needed

24

Starts

2018-05-31

Expected to finish

2021-08-31

Last updated by the study team

2023-04-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• Refusal of consent (in those subjects approached for consent where required by local institutional procedures)
• Treatment of methemoglobinemia with another methylene blue product

Where it is running

• 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

Full record on ClinicalTrials.gov

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