Aortic Stenosis (Treated With TAVI)
Conditions
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.
Interventions
DRUGNormal saline
Participants in Control group are administered IV 100cc normal saline & IM normal saline (1cc) 1 day before surgery.
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
Intervention model description
Patients are divided into 2 groups, who are administered Iron isomaltoside & Vitamin B12 or who are administered Normal saline (N/S).
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin (Hb) concentration | 1~3 days before TAVI (Baseline) | Compare the Hb concentrations between the Iron isomaltoside group and the Control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion requirement | 1~3 days before TAVI (Baseline) | Compare the transfusion requirement between the Iron isomaltoside group and the Control group. |
| Functional performance - Essential frailty toolset (EFT) | 1~3 days before TAVI (Baseline) | Compare the functional performance between the Iron isomaltoside group and the Control group. |
| Functional performance - Handgrip | 1~3 days before TAVI (Baseline) | Compare the functional performance between the Iron isomaltoside group and the Control group. |
| Cognitive function - MMSE-K (Mini Mental State Exam) | 1~3 days before TAVI (Baseline) | Compare the cognitive function between the Iron isomaltoside group and the Control group. |
| Depression - SGDS-K (Short geriatric Depression Scale) | 1~3 days before TAVI (Baseline) | Compare the depression between the Iron isomaltoside group and the Control group. |
Countries
South Korea
Contacts
Primary ContactJong Wook Song
Outcome results
None listed