Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation

Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation: a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis (Treated With TAVI)
• Intervention / Treatment: Drug: Normal saline; Drug: Iron isomaltoside

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jong Wook Song; Phone Number: 82-2-2224-3971; Email: SJW72331@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
    • Contact: Jong Wook Song; Phone Number: 82-2-2224-3971; Email: SJW72331@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Participants in this group are administered N/S.	Drug: Normal saline; Participants in "Control group" are administered IV 100cc normal saline & IM normal saline (1cc) 1 day before surgery.
Experimental: Iron isomaltoside group; Participants in this group are administered Iron isomaltoside & Vitamin B12.	Drug: Iron isomaltoside; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Hematinics; Iron isomaltoside 1000
• Other Study ID Numbers: 4-2020-0143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No