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

NCT ID: NCT04346004

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2023-03-31

Brief Summary

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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

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Conditions

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Aortic Stenosis (Treated With TAVI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.

Study Groups

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Control group

Participants in this group are administered N/S.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Iron isomaltoside group

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

Group Type EXPERIMENTAL

Iron isomaltoside

Intervention Type 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.

Interventions

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Normal saline

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jong Wook Song

Role: CONTACT

Phone: 82-2-2224-3971

Email: [email protected]

Facility Contacts

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Jong Wook Song

Role: primary

Other Identifiers

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4-2020-0143

Identifier Type: -

Identifier Source: org_study_id