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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
214
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.
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGHemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Time frame: 1~3 days before TAVI (Baseline)
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Time frame: within 5 minutes after TAVI
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Time frame: 2 days after TAVI
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Time frame: 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)
Transfusion requirement
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Time frame: 1~3 days before TAVI (Baseline)
Transfusion requirement
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Time frame: 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.
Time frame: 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.
Time frame: 1~3 days before TAVI (Baseline)
Functional performance - Handgrip
Compare the functional performance between the Iron isomaltoside group and the Control group.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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