Center of Clinical Research Dalarna
Falun, 79182, Sweden
NCT Number: NCT06309641
Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose.
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Notify Me18 year and older
All sexes
Observational
Falun, 79182, Sweden
Methemoglobin is an isoform of hemoglobin without oxygen carrying properties. Higher levels of methemoglobin may impact oxygen transport of the blood and increase the risk of tissue hypoxia. Methemoglobinemia has been reported as side effect of different drugs such as antibiotics or local anesthetics, but not after iron preparations. There is only one case report of increased levels of methemoglobin following intravenous iron therapy.
Patients with anemia due to iron deficiency can be treated with intravenous iron preparations such as ferric carboxymaltose or ferric derisomaltose. Anemia itself reduces oxygen transport of the blood, increasing the risk of tissue hypoxia due to methemoglobinemia in those patients.
This study aims to assess methemoglobinemia following treatment with intravenous iron in patients with anemia. The report will include case reports of patients with severe anemia who developed methemoglobinemia following treatment with ferric derisomaltose. Furthermore, methemoglobin levels are evaluated before and after intravenous iron administration in a cohort of adult patients with anemia who are scheduled to receive ferric carboxymaltose or ferric derisomaltose in routine care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients in the cohort study:
for patients in the case report:
Exclusion criteria
Blood samples for measurement of methemoglobin are obtained directly before and 30-120 minutes after drug administration.
Description of clinical course and methemoglobin levels in patients with severe anemia who developed methemoglobinemia after intravenous administration of ferric derisomaltose.
Time frame: 30-120 minutes after start of iron administration
Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric derisomaltose.
Time frame: 30-120 minutes after start of iron administration
Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric carboxymaltose.
Time frame: 30-120 minutes after start of iron administration
Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on drug dosage
Time frame: 30-120 minutes after start of iron administration
Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on age.
Time frame: 30-120 minutes after start of iron administration
Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on sex.
Time frame: 30-120 minutes after start of iron administration
Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on hemoglobin level before treatment.
Time frame: 30-120 minutes after start of iron administration
Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on blood levels of ferritin, transferrin or iron.
Time frame: 30-120 minutes after start of iron administration
Association between change of methemoglobin (percent) in venous blood and change of lactate in venous blood after compared to before treatment with intravenous iron.
Claudia Seiler
Other
Methemoglobinemia Following Intravenous Iron Treatment Administered as Ferric Carboxymaltose or Ferric Derisomaltose in Patients With Anemia
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