Aortic Stenosis (Treated With TAVI) Clinical Trial
Official title:
Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation: a Randomized Clinical Trial
| Verified date | April 2020 |
| Source | Yonsei University |
| Contact | Jong Wook Song |
| Phone | 82-2-2224-3971 |
| SJW72331[@]yuhs.ac | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 214 |
| Est. completion date | March 2023 |
| Est. primary completion date | March 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hemoglobin (Hb) concentration | Compare the Hb concentrations between the Iron isomaltoside group and the Control group. | 1~3 days before TAVI (Baseline) | |
| Primary | Hemoglobin (Hb) concentration | Compare the Hb concentrations between the Iron isomaltoside group and the Control group. | within 5 minutes after TAVI | |
| Primary | Hemoglobin (Hb) concentration | Compare the Hb concentrations between the Iron isomaltoside group and the Control group. | 2 days after TAVI | |
| Primary | 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 | Transfusion requirement | Compare the transfusion requirement between the Iron isomaltoside group and the Control group. | 1~3 days before TAVI (Baseline) | |
| Secondary | 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 | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | Functional performance - Handgrip | Compare the functional performance between the Iron isomaltoside group and the Control group. | 1~3 days before TAVI (Baseline) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) |