Clinical trial NCT04346004: Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation
Official title: Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aortic Stenosis (Treated With TAVI)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 214
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are divided into 2 groups, who are administered Iron isomaltoside \& Vitamin B12 or who are administered Normal saline (N/S).
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Hemoglobin (Hb) concentration
timeFrame: 1~3 days before TAVI (Baseline)
measure: Hemoglobin (Hb) concentration
timeFrame: within 5 minutes after TAVI
measure: Hemoglobin (Hb) concentration
timeFrame: 2 days after TAVI
measure: Hemoglobin (Hb) concentration
timeFrame: 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 outcomes:
measure: Transfusion requirement
timeFrame: 1~3 days before TAVI (Baseline)
measure: Transfusion requirement
timeFrame: During hospitalization period after TAVI, an average of 1 week
measure: Transfusion requirement
timeFrame: 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)
measure: Functional performance - Essential frailty toolset (EFT)
timeFrame: 1~3 days before TAVI (Baseline)
measure: Functional performance - Handgrip
timeFrame: 1~3 days before TAVI (Baseline)
measure: Functional performance - Essential frailty toolset (EFT)
timeFrame: 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: Functional performance - Handgrip
timeFrame: 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: Cognitive function - MMSE-K (Mini Mental State Exam)
timeFrame: 1~3 days before TAVI (Baseline)
measure: Cognitive function - MMSE-K (Mini Mental State Exam)
timeFrame: 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: Depression - SGDS-K (Short geriatric Depression Scale)
timeFrame: 1~3 days before TAVI (Baseline)
measure: Depression - SGDS-K (Short geriatric Depression Scale)
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References: