Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patie… (NCT04346004) | Clinical Trial Compass
UnknownPhase 4
Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation
South Korea214 participantsStarted 2020-04-27
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hemoglobin (Hb) concentration
Timeframe: 1~3 days before TAVI (Baseline)
2
Hemoglobin (Hb) concentration
Timeframe: within 5 minutes after TAVI
3
Hemoglobin (Hb) concentration
Timeframe: 2 days after TAVI
4
Hemoglobin (Hb) concentration
Timeframe: 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)