Acquired Methemoglobinemia Observational Registry (metHb)

• ClinicalTrials.gov Identifier: NCT03542760
• Recruitment Status: Active, not recruiting
• First Posted: May 31, 2018
• Last Update Posted: July 8, 2021
• Sponsor: Hospital Quality Foundation
• Collaborator: Prove pharm
• Information provided by (Responsible Party): Hospital Quality Foundation

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Methemoglobinemia, Acquired; Methemoglobinemia	Drug: Methylene Blue

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 29 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Target Follow-Up Duration: 10 Days
• Official Title: Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)
• Actual Study Start Date: May 31, 2018
• Actual Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: August 31, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Primary Treated Group; 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; Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care
Secondary Treated Group; Subjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms	Drug: Methylene Blue; Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 pressue 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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Patients who present in hospital / urgent care setting diagnosed with acquired methemoglobinemia.

Criteria

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

Contacts and Locations

Locations

United States, Michigan

Henry Ford Health System

Detroit, Michigan, United States, 48202

Sponsors and Collaborators

Hospital Quality Foundation

Prove pharm

Investigators

• Principal Investigator: Charles V Pollack, MD; Hospital Quality Foundation

More Information

Additional Information:

• Responsible Party: Hospital Quality Foundation
• ClinicalTrials.gov Identifier: NCT03542760
• Other Study ID Numbers: HQF-METHB-2018001
• First Posted: May 31, 2018
• Last Update Posted: July 8, 2021
• Last Verified: July 2021

Keywords provided by Hospital Quality Foundation:

Methylene Blue

Additional relevant MeSH terms:

Methemoglobinemia; Hematologic Diseases; Methylene Blue; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action