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

NCT04346004 | Unknown Phase 4

• 1 other identifier: 4-2020-0143
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis (Treated With TAVI)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Transfusion requirement

  1~3 days before TAVI (Baseline)

• Transfusion requirement

  During hospitalization period after TAVI, an average of 1 week

• 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)

• Functional performance - Essential frailty toolset (EFT)

  1~3 days before TAVI (Baseline)

• Functional performance - Handgrip

  1~3 days before TAVI (Baseline)

Study Arms (2)

Control group

PLACEBO COMPARATOR

Participants in this group are administered N/S.

Drug: Normal saline

Iron isomaltoside group

EXPERIMENTAL

Participants in this group are administered Iron isomaltoside \& Vitamin B12.

Drug: Iron isomaltoside

Interventions

Normal saline DRUG

Participants in "Control group" are administered IV 100cc normal saline \& IM normal saline (1cc) 1 day before surgery.

Control group

Iron isomaltoside DRUG

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.

Iron isomaltoside group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 60 years and undergoing transcatheter aortic valve implantation (TAVI)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Saline Solution; iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Jong Wook Song

CONTACT

82-2-2224-3971; SJW72331@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are divided into 2 groups, who are administered Iron isomaltoside \& Vitamin B12 or who are administered Normal saline (N/S).

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 15, 2020
• Study Start: April 27, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)