search
Back to results

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

Primary Purpose

Aortic Stenosis (Treated With TAVI)

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Normal saline
Iron isomaltoside
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aortic Stenosis (Treated With TAVI)

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Iron isomaltoside group

Arm Description

Participants in this group are administered N/S.

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

Outcomes

Primary Outcome Measures

Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.

Secondary Outcome Measures

Transfusion requirement
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Transfusion requirement
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Transfusion requirement
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Functional performance - Essential frailty toolset (EFT)
Compare the functional performance between the Iron isomaltoside group and the Control group.
Functional performance - Handgrip
Compare the functional performance between the Iron isomaltoside group and the Control group.
Functional performance - Essential frailty toolset (EFT)
Compare the functional performance between the Iron isomaltoside group and the Control group.
Functional performance - Handgrip
Compare the functional performance between the Iron isomaltoside group and the Control group.
Cognitive function - MMSE-K (Mini Mental State Exam)
Compare the cognitive function between the Iron isomaltoside group and the Control group.
Cognitive function - MMSE-K (Mini Mental State Exam)
Compare the cognitive function between the Iron isomaltoside group and the Control group.
Depression - SGDS-K (Short geriatric Depression Scale)
Compare the depression between the Iron isomaltoside group and the Control group.
Depression - SGDS-K (Short geriatric Depression Scale)
Compare the depression between the Iron isomaltoside group and the Control group.

Full Information

First Posted
April 6, 2020
Last Updated
April 28, 2020
Sponsor
Yonsei University
search

1. Study Identification

Unique Protocol Identification Number
NCT04346004
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis (Treated With TAVI)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients are divided into 2 groups, who are administered Iron isomaltoside & Vitamin B12 or who are administered Normal saline (N/S).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
Allocation
Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants in this group are administered N/S.
Arm Title
Iron isomaltoside group
Arm Type
Experimental
Arm Description
Participants in this group are administered Iron isomaltoside & Vitamin B12.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Participants in "Control group" are administered IV 100cc normal saline & IM normal saline (1cc) 1 day before surgery.
Intervention Type
Drug
Intervention Name(s)
Iron isomaltoside
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin (Hb) concentration
Description
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Time Frame
1~3 days before TAVI (Baseline)
Title
Hemoglobin (Hb) concentration
Description
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Time Frame
within 5 minutes after TAVI
Title
Hemoglobin (Hb) concentration
Description
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Time Frame
2 days after TAVI
Title
Hemoglobin (Hb) concentration
Description
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Time Frame
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 Measure Information:
Title
Transfusion requirement
Description
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Time Frame
1~3 days before TAVI (Baseline)
Title
Transfusion requirement
Description
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Time Frame
During hospitalization period after TAVI, an average of 1 week
Title
Transfusion requirement
Description
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Time Frame
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)
Title
Functional performance - Essential frailty toolset (EFT)
Description
Compare the functional performance between the Iron isomaltoside group and the Control group.
Time Frame
1~3 days before TAVI (Baseline)
Title
Functional performance - Handgrip
Description
Compare the functional performance between the Iron isomaltoside group and the Control group.
Time Frame
1~3 days before TAVI (Baseline)
Title
Functional performance - Essential frailty toolset (EFT)
Description
Compare the functional performance between the Iron isomaltoside group and the Control group.
Time Frame
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)
Title
Functional performance - Handgrip
Description
Compare the functional performance between the Iron isomaltoside group and the Control group.
Time Frame
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)
Title
Cognitive function - MMSE-K (Mini Mental State Exam)
Description
Compare the cognitive function between the Iron isomaltoside group and the Control group.
Time Frame
1~3 days before TAVI (Baseline)
Title
Cognitive function - MMSE-K (Mini Mental State Exam)
Description
Compare the cognitive function between the Iron isomaltoside group and the Control group.
Time Frame
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)
Title
Depression - SGDS-K (Short geriatric Depression Scale)
Description
Compare the depression between the Iron isomaltoside group and the Control group.
Time Frame
1~3 days before TAVI (Baseline)
Title
Depression - SGDS-K (Short geriatric Depression Scale)
Description
Compare the depression between the Iron isomaltoside group and the Control group.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Wook Song
Phone
82-2-2224-3971
Email
SJW72331@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Wook Song
Phone
82-2-2224-3971
Email
SJW72331@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs