Acquired Methemoglobinemia Observational Registry

Study Overview
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Brief Summary
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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.

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

Conditions
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Methemoglobinemia, Acquired, Methemoglobinemia

Intervention / Treatment
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* Drug: Methylene Blue


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Treated Group<br>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%. | Drug: Methylene Blue<br>* Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care<br>|
| Secondary Treated Group<br>Subjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms | Drug: Methylene Blue<br>* Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Methemoglobin 1h after Administration of ProvayBlue | Level of methemoglobin 1h after administration of ProvayBlue for treatment of acquired methemoglobinemia compared to pre-treatment level of methemoglobin. | 1h post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Normalization of Respiratory Rate | Time to normalization of respiratory rate after administration of ProvayBlue for treatment of acquired methemoglobinemia. | Index Hospitalization | 
| Time to Normalization of Heart Rate | Time to normalization of heart rate after administration of ProvayBlue for treatment of acquired methemoglobinemia. | Index Hospitalization | 
| Time to Normalization of Blood Pressure | Time to normalization of blood pressure after administration of ProvayBlue for treatment of acquired methemoglobinemia. | Index Hospitalization | 
| Prevalence and Nature of Adverse Events | Prevalence and nature of any adverse events occurring within 10 days of the administration of ProvayBlue | Within 10 days of Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methylene Blue