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OpenTrials
Completed

NCT Number: NCT03542760

Acquired Methemoglobinemia Observational Registry

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.

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Key information

Conditions

Methemoglobinemia, Acquired Hematologic Diseases Hemic and Lymphatic Diseases Methemoglobinemia

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars Sinai, Los Angeles, California, United States

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylene Blue

Drug

Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care

Primary outcomes

  1. Reduction of Methemoglobin 1h after Administration of ProvayBlue

    Time frame: 1h post-treatment

    Level of methemoglobin 1h after administration of ProvayBlue for treatment of acquired methemoglobinemia compared to pre-treatment level of methemoglobin.

Secondary outcomes

  1. Time to Normalization of Respiratory Rate

    Time frame: Index Hospitalization

    Time to normalization of respiratory rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.

  2. Time to Normalization of Heart Rate

    Time frame: Index Hospitalization

    Time to normalization of heart rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.

  3. Time to Normalization of Blood Pressure

    Time frame: Index Hospitalization

    Time to normalization of blood pressure after administration of ProvayBlue for treatment of acquired methemoglobinemia.

  4. Prevalence and Nature of Adverse Events

    Time frame: Within 10 days of Treatment

    Prevalence and nature of any adverse events occurring within 10 days of the administration of ProvayBlue

Other outcomes

  1. Prevalence by Agent

    Time frame: Index Hospitalization

    Prevalence of acquired methemoglobinemia cases by suspected causal agent

  2. Resolution of Symptoms

    Time frame: Index Hospitalization

    Resolution of methemoglobinemia-related symptoms during the index hospitalization

Sponsors and collaborators

Lead sponsor

Hospital Quality Foundation

Other

Collaborators

  • Prove pharm

Registry information

Official study title

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

Acronym: metHb

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 31, 2018
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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