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

  • STATUS
    Recruiting
  • End date
    Mar 25, 2023
  • participants needed
    214
  • sponsor
    Yonsei University
Updated on 25 January 2021
stenosis
transcatheter aortic valve implantation
tavi

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.

Details
Condition Aortic Stenosis, VALVULAR HEART DISEASE, Heart Valve Disease, Heart Valve Disease, aortic valve stenosis
Treatment Normal saline, Iron isomaltoside
Clinical Study IdentifierNCT04346004
SponsorYonsei University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients older than 60 years and undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria

Emergency operation
Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
Infectious condition
Active bleeding
Hypokalemia
Severe chronic kidney disease (GFR(CKD-EPI) <30mL/min/1.73m2) or Dialysis
Patients taking erythropoietin
Aplastic anemia, Hemolytic anemia
Hemochromatosis, Hemosiderosis
Uncompensated liver cirrhosis, Acute hepatitis, Alcoholism
Peptic / Duodenal ulcer, Crohn's disease, Ulcerative colitis
Allergy to iron supplements or vitamin B12
Symptomatic asthma, eczema
Immunologic disease (e.g. Rheumatoid arthritis, Systemic lupus erythematosus)
Malignancy
Patients being treated in the intensive care unit due to heart failure or other major complications
Patients who participated in other clinical studies that could affect prognosis
Patients who cannot understand the informed consent (eg. Foreigner)
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