Actively Recruiting
Improved Recovery by Iron Following Surgery With Blood Loss, a Double-blind Multi-centre Randomized Controlled Phase III Drug Trial (the IRIS-trial)
Led by Jon Unosson · Updated on 2024-10-21
338
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether an intravenous iron treatment called Ferric Carboxymaltose can help improve recovery after major surgeries that cause blood loss, such as complex aortic surgery or liver and pancreatic resections. Post-operative anemia, often caused by pre-existing iron deficiency and blood loss during surgery, can slow recovery. This Phase III randomized controlled trial aims to see if giving Ferric Carboxymaltose after surgery reduces the need for blood transfusions and improves health outcomes. Participants who experience blood loss between 400 and 4000 ml during surgery are randomly assigned to receive either a single intravenous dose of 1000 mg Ferric Carboxymaltose or a placebo (saline solution). This treatment is given by infusion as soon as the surgery ends. The study compares these two groups to evaluate differences in recovery and anemia outcomes over the following weeks. During the study, participants are monitored for up to five weeks after surgery. Researchers assess recovery by looking at death rates, red blood cell transfusions, severe anemia occurrences, and quality of life measures. They also track hemoglobin levels, complications, overall recovery, performance status, hospital readmissions, and long-term outcomes from medical records. The study continues until a set number of patients have completed follow-up to fully evaluate the effects of the iron treatment.
CONDITIONS
Brief Title
Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of written informed consent
- Male and female patients
- Weight > 50 kg
- Age over 18 years
- Scheduled for complex aortic surgery, liver resection or pancreatic resection
You will not qualify if you...
- Expected survival less than six months
- Intravenous iron therapy within one month prior to surgery
- Severe anemia (B-Hb <80 mg/L) prior to surgery
- Contraindication to Ferric Carboxymaltose
- Iron overloading disorder such as hemochromatosis
- Risk of small future liver remnant
- Pre-operative renal replacement therapy
- Participation in another drug or device study within 30 days before enrollment
- Planned major surgery before five week follow-up
- Unsuitable for inclusion according to investigator
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with follow-up up to 5 weeks
Participants receive a single intravenous dose of either Ferric Carboxymaltose or placebo after surgery with blood loss.
1 baseline treatment visit and weekly follow-up visits for up to 5 weeks
Trial Site Locations
Total: 1 location
1
Uppsala University Hospital
Uppsala, Sverige, Sweden
Actively Recruiting
Research Team
J
Jon Unosson, MDPhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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