Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation
- Conditions
- Aortic Stenosis (Treated With TAVI)
- Interventions
- Drug: Normal saline
- Registration Number
- NCT04346004
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 214
- Patients older than 60 years and undergoing transcatheter aortic valve implantation (TAVI)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Normal saline Participants in this group are administered N/S. Iron isomaltoside group Iron isomaltoside Participants in this group are administered Iron isomaltoside \& Vitamin B12.
- Primary Outcome Measures
Name Time Method Hemoglobin (Hb) concentration 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) Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
- Secondary Outcome Measures
Name Time Method Transfusion requirement 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) Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Functional performance - Handgrip 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) Compare the functional performance between the Iron isomaltoside group and the Control group.
Functional performance - Essential frailty toolset (EFT) 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) Compare the functional performance between the Iron isomaltoside group and the Control group.
Depression - SGDS-K (Short geriatric Depression Scale) 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) Compare the depression between the Iron isomaltoside group and the Control group.
Cognitive function - MMSE-K (Mini Mental State Exam) 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) Compare the cognitive function between the Iron isomaltoside group and the Control group.
Trial Locations
- Locations (1)
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of