Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency (NCT03817957) | Clinical Trial Compass
CompletedPhase 3
Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency
Germany187 participantsStarted 2018-09-18
Plain-language summary
Iron deficiency anaemia (IDA) in postoperative patients with confirmed preoperative iron deficiency (ID) in a population with planned major surgery who need fast replenishment of iron as judged by the treating physician will be treated with i.v. iron using Polyglucoferron, Ferric Carboxymaltose or oral iron
Who can participate
Age range
18 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.
Exclusion criteria
. known sensitivity to iron or an ingredient of the investigational products
. Significant history of systemic allergic reactions
. Haemachromatosis, thalassemia or TSAT \>50% as indicator of iron overload
. Acute or chronic intoxication
. Infection (patient on non-prophylactic antibiotics)
. Chronic liver disease and/or screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) above three times the upper limit of the normal range
. according to Summary of product characteristics (SmPC)
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
Proportion of patients who achieve normalized Hb-levels or increased Hb of at least 1.5 g/dl
Timeframe: Baseline to approximately 30 days post-baseline (visit 4)
2
pre post difference of volumen-corrected urine iron levels
Timeframe: urine sampled prior to administration and approximately 1 to 8 hours post-baseline