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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Participants in this group are administered N/S. |
|
| Iron isomaltoside group | Experimental | Participants in this group are administered Iron isomaltoside & Vitamin B12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | Participants in "Control group" are administered IV 100cc normal saline & IM normal saline (1cc) 1 day before surgery. |
|
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Wook Song | Contact | 82-2-2224-3971 | SJW72331@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Recruiting | Seoul | South Korea |
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Patients are divided into 2 groups, who are administered Iron isomaltoside & Vitamin B12 or who are administered Normal saline (N/S).
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Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
| Iron isomaltoside | Drug | 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. |
|
| 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) |
|
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| C557707 | iron isomaltoside 1000 |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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