Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
Study NCT ID:
NCT04346004
Status:
UNKNOWN
Last Update Posted:
2020-04-30
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation: a Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
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:
Transcatheter aortic valve implantation (TAVI) is a standard procedure for severe aortic stenosis patients with moderate or higher risk of surgery. Several studies have reported the adverse effects of blood disorders, such as anemia and iron deficiency, on the prognosis of patients undergoing TAVI, and many other studies have been conducted to find ways to prevent them.
Iron isomaltoside, the latest intravenous iron supplement, can effectively replenish iron store with a single high-dose injection. Research has shown that a preoperative single high-dose iron isomaltoside (1000mg) safely increased hemoglobin levels after surgery in patients undergoing cardiac surgery. However, there have been no studies on the effect of ultra-short-term use of intravenous iron supplements prior to TAVI procedure.
Therefore, we investigate the effect of a single high-dose of iron isomaltoside (20mg/kg, maximum dose: 1g) on the hemoglobin concentration after the TAVI.
Iron isomaltoside, the latest intravenous iron supplement, can effectively replenish iron store with a single high-dose injection. Research has shown that a preoperative single high-dose iron isomaltoside (1000mg) safely increased hemoglobin levels after surgery in patients undergoing cardiac surgery. However, there have been no studies on the effect of ultra-short-term use of intravenous iron supplements prior to TAVI procedure.
Therefore, we investigate the effect of a single high-dose of iron isomaltoside (20mg/kg, maximum dose: 1g) on the hemoglobin concentration after the TAVI.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: