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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation: a Randomized Clinical Trial

Conditions
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Aortic Stenosis (Treated With TAVI)

Intervention / Treatment
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* Drug: Normal saline
* Drug: Iron isomaltoside


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are divided into 2 groups, who are administered Iron isomaltoside & Vitamin B12 or who are administered Normal saline (N/S).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Participants in this group are administered N/S. | Drug: Normal saline<br>* Participants in Control group are administered IV 100cc normal saline & IM normal saline (1cc) 1 day before surgery.<br>|
| Experimental: Iron isomaltoside group<br>Participants in this group are administered Iron isomaltoside & Vitamin B12. | Drug: Iron isomaltoside<br>* Participants in Iron isomaltoside group are administered IV Iron maltoside diluted in 100 cc normal saline (20mg/kg, maximum dose: 1g) & IM Vitamin B12 (1mg) 1 day before surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin (Hb) concentration | Compare the Hb concentrations between the Iron isomaltoside group and the Control group. | 1 3 days before TAVI (Baseline) | 
| Hemoglobin (Hb) concentration | Compare the Hb concentrations between the Iron isomaltoside group and the Control group. | within 5 minutes after TAVI | 
| Hemoglobin (Hb) concentration | Compare the Hb concentrations between the Iron isomaltoside group and the Control group. | 2 days after TAVI | 
| Hemoglobin (Hb) concentration | Compare the Hb concentrations between the Iron isomaltoside group and the Control group. | 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion requirement | Compare the transfusion requirement between the Iron isomaltoside group and the Control group. | 1 3 days before TAVI (Baseline) | 
| Transfusion requirement | Compare the transfusion requirement between the Iron isomaltoside group and the Control group. | During hospitalization period after TAVI, an average of 1 week | 
| Transfusion requirement | Compare the transfusion requirement between the Iron isomaltoside group and the Control group. | During 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or until 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks) | 
| Functional performance - Essential frailty toolset (EFT) | Compare the functional performance between the Iron isomaltoside group and the Control group. | 1 3 days before TAVI (Baseline) | 
| Functional performance - Handgrip | Compare the functional performance between the Iron isomaltoside group and the Control group. | 1 3 days before TAVI (Baseline) | 
| Functional performance - Essential frailty toolset (EFT) | Compare the functional performance between the Iron isomaltoside group and the Control group. | 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks) | 
| Functional performance - Handgrip | Compare the functional performance between the Iron isomaltoside group and the Control group. | 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks) | 
| Cognitive function - MMSE-K (Mini Mental State Exam) | Compare the cognitive function between the Iron isomaltoside group and the Control group. | 1 3 days before TAVI (Baseline) | 
| Cognitive function - MMSE-K (Mini Mental State Exam) | Compare the cognitive function between the Iron isomaltoside group and the Control group. | 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks) | 
| Depression - SGDS-K (Short geriatric Depression Scale) | Compare the depression between the Iron isomaltoside group and the Control group. | 1 3 days before TAVI (Baseline) | 
| Depression - SGDS-K (Short geriatric Depression Scale) | Compare the depression between the Iron isomaltoside group and the Control group. | 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks) |