Acquired Methemoglobinemia Observational Registry
metHb
Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)
1 other identifier
observational
24
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2018
Typical duration for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 31, 2018
CompletedStudy Start
First participant enrolled
May 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedApril 12, 2023
April 1, 2023
3.1 years
May 20, 2018
April 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Time to Normalization of Respiratory Rate
Index Hospitalization
Time to Normalization of Heart Rate
Index Hospitalization
Time to Normalization of Blood Pressure
Index Hospitalization
Prevalence and Nature of Adverse Events
Within 10 days of Treatment
Other Outcomes (2)
Prevalence by Agent
Index Hospitalization
Resolution of Symptoms
Index Hospitalization
Study Arms (2)
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%.
Secondary Treated Group
Subjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms
Interventions
Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care
Eligibility Criteria
Patients who present in hospital / urgent care setting diagnosed with acquired methemoglobinemia.
You may qualify if:
- 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
You may not qualify if:
- Refusal of consent (in those subjects approached for consent where required by local institutional procedures)
- Treatment of methemoglobinemia with another methylene blue product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Quality Foundationlead
- Prove pharmcollaborator
Study Sites (32)
Cedars Sinai
Los Angeles, California, 90048, United States
UC Davis Health
Sacramento, California, 95817, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Palmetto General
Palm Beach Gardens, Florida, 33410, United States
Tampa General
Tampa, Florida, 33606, United States
IU Health
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Health System
Kansas City, Kansas, 66160, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Partners Healthcare; Brigham and Women's
Boston, Massachusetts, 02115, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
St John Medical Center
Detroit, Michigan, 48236, United States
HealthPartners Regions
Saint Paul, Minnesota, 55101, United States
Washington University
St Louis, Missouri, 63110, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
New York Methodist
New York, New York, 10032, United States
Carolinas Medical Center
Charlotte, North Carolina, 28207, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals
Cleveland, Ohio, 44106, United States
Mercy Health
Youngstown, Ohio, 44501, United States
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38104, United States
UT Southwestern
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98195, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles V Pollack, MD
Hospital Quality Foundation
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2018
First Posted
May 31, 2018
Study Start
May 31, 2018
Primary Completion
June 30, 2021
Study Completion
August 31, 2021
Last Updated
April 12, 2023
Record last verified: 2023-04