Acquired Methemoglobinemia Observational Registry (metHb)

Hospital Quality Foundation

Status: Completed

Conditions: Methemoglobinemia; Methemoglobinemia, Acquired

Treatments: Drug: Methylene Blue

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03542760

HQF-METHB-2018001

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

24 participants in 2 patient groups

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%.

Treatment:

Drug: Methylene Blue

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

Treatment:

Drug: Methylene Blue