Assessing methemoglobinemia after intravenous iron treatment
Methemoglobinemia Following Intravenous Iron Treatment Administered As Ferric Carboxymaltose or Ferric Derisomaltose in Patients with Anemia
This study is trying to see if intravenous iron treatments for anemia can cause a condition called methemoglobinemia, which affects how well blood carries oxygen.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dalarna County Council, Sweden Academic / other |
| Locations | 1 site (Falun) |
| Trial ID | NCT06309641 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate methemoglobin levels in patients with anemia who receive intravenous iron treatments, specifically ferric carboxymaltose or ferric derisomaltose. It seeks to identify any occurrences of methemoglobinemia, a condition where hemoglobin is unable to carry oxygen effectively, as a potential side effect of these iron therapies. The study will include case reports of patients with severe anemia who developed methemoglobinemia and will assess methemoglobin levels before and after treatment in a cohort of adult patients. This research addresses a previously unreported side effect of intravenous iron therapy.
Who should consider this trial
Good fit: Ideal candidates include adults with anemia who are prescribed intravenous iron treatments like ferric carboxymaltose or ferric derisomaltose.
Not a fit: Patients who have known or suspected genetic methemoglobinemia or those who have received intravenous iron within the week prior to sampling may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety profile of intravenous iron treatments for anemia by identifying risks associated with methemoglobinemia.
How similar studies have performed: While methemoglobinemia has been reported as a side effect of other medications, this study's focus on intravenous iron treatments is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: for patients in the cohort study: * anemia * prescription of administration of intravenous iron (ferric carboxymaltose or ferric derisomaltose) for patients in the case report: - patients with severe anemia who developed methemoglobinemia following administration of ferric derisomaltose Exclusion Criteria: * declined consent * known or suspected methemoglobinemia of genetic or other origin * previous administration of intravenous iron within one week before study sampling.
Where this trial is running
Falun
- Center of Clinical Research Dalarna — Falun, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.