NCT03542760

Acquired Methemoglobinemia Observational Registry

Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Hospital Quality Foundation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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.

Conditions

• Methemoglobinemia, Acquired
• Methemoglobinemia

Interventions

Type	Name	Description
DRUG	Methylene Blue	Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care

Timeline

• Start date: 2018-05-31
• Primary completion: 2021-06-30
• Completion: 2021-08-31
• First posted: 2018-05-31
• Last updated: 2023-04-12

Locations

32 sites across 1 country: United States