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Improved Recovery by Iron following Surgery with blood loss, a double-blind multi-centre randomized controlled phase III drug trial (the IRIS-trial)
EU CTIS ID: 2022-502776-22-00
What this study is testing
To examine if 1000 mg iv Ferric Carboxymaltose administered immediately following hepatic or pancreatic resection or complex aortic surgery with 400 – 4000 ml perioperative blood loss affect a composite of death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L) and change in quality of life five weeks post operatively using FACT-An QoL questionnaire
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provision of written informed consent
- Male and female participants
- Weight > 50 kg
- > 18 years of age
- Scheduled for complex aortic surgery, liver resection or pancreatic resection
You likely can't join if
- Short expected survival (less than six months)
- Unsuitable for inclusion according to the investigator
- Pregnancy or breastfeeding
- Intra-venous iron therapy within one month prior to surgery
- Severe anaemia (B-Hb <80 mg/L) prior to surgery
- Contraindication to Ferric Carboxymaltose according to SmPC
See the full eligibility criteria
- Provision of written informed consent
- Male and female participants
- Weight > 50 kg
- > 18 years of age
- Scheduled for complex aortic surgery, liver resection or pancreatic resection
- Short expected survival (less than six months)
- Unsuitable for inclusion according to the investigator
- Pregnancy or breastfeeding
- Intra-venous iron therapy within one month prior to surgery
- Severe anaemia (B-Hb <80 mg/L) prior to surgery
- Contraindication to Ferric Carboxymaltose according to SmPC
- Iron overloading disorder, i.e. hemochromatosis
- Risk of small for size future liver remnant
- Pre-operative renal replacement therapy
- Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study
- Another planned major surgical procedure before the five week follow up
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.