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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Aortic Stenosis (Treated With TAVI)

Treatments: Drug: Normal saline; Drug: Iron isomaltoside

Study type: Interventional

Funder types: Other

Identifiers

NCT04346004

4-2020-0143

Details and patient eligibility

About

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.

Enrollment: 214 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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214 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Participants in this group are administered N/S.

Treatment:

Drug: Normal saline

Iron isomaltoside group

Experimental group

Description:

Participants in this group are administered Iron isomaltoside \& Vitamin B12.

Treatment:

Drug: Iron isomaltoside