Status:
UNKNOWN
Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation
Lead Sponsor:
Yonsei University
Conditions:
Aortic Stenosis (Treated With TAVI)
Eligibility:
All Genders
60+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Patients older than 60 years and undergoing transcatheter aortic valve implantation (TAVI)
Exclusion
- 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)
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04346004
Start Date
April 27 2020
End Date
March 1 2023
Last Update
April 30 2020
Active Locations (1)
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1
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea