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New treatment option for Surgery
Official title Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial
ClinicalTrials.gov ID: NCT05744219
What this study is testing
What is Ferric carboxymaltose?
Ferric carboxymaltose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss. Post-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (IDA) and per-operative blood loss.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of written informed consent
- Male and female patients
- 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)
- 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
See the full eligibility criteria
- Provision of written informed consent
- Male and female patients
- Weight \> 50 kg
- \> 18 years of age
- Scheduled for complex aortic surgery, liver resection or pancreatic resection
- Short expected survival (less than six months)
- 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
- Unsuitable for inclusion according to the investigator
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Uppsala, Sverige, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Uppsala, Sverige, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.