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IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI

NCT04797832 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-10-27

No results posted yet for this study

Summary

Iron deficiency is common among patients undergoing TAVI. It is estimated at 54-79%. Previous non-randomized small trial have shown symptomatic benefit in treating iron deficiency in this group of patients.

The investigators predict, that as IV iron will improve symptoms, quality of life and exercise tolerance in this group of patients.

Conditions

  • Iron Deficiency Anemia Due to Blood Loss
  • Aortic Stenosis

Interventions

DRUG

IV Sodium Ferric Gluconate Complex

125 mg of IV Iron per day to 3 to 5 days according to hospitalisation length.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Erez Marcusohn, MD · Cardiology Department, Rambam Health Care Campus,Haifa,Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-18
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797832 on ClinicalTrials.gov