drugset / Trial / NCT04346004

Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation

NCT04346004

Phase 4 Unknown 214 enrolled Yonsei University
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2020-04-27
Primary completion
2023-03
Completion
2023-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Iron isomaltoside 1000 Unknown 20 mg/kg Intravenous
Background Vitamin B12 Other / unclassified 1 mg Intramuscular

Indications