Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309641
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-07
Brief Title:
Methemoglobinemia Following Intravenous Iron Treatment
Sponsor:
Claudia Seiler
Organization:
Dalarna County Council Sweden
Study Overview
Official Title:
Methemoglobinemia Following Intravenous Iron Treatment Administered As Ferric Carboxymaltose or Ferric Derisomaltose in Patients with Anemia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None