NCT05744219: IRIS

Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial

Recruiting now Phase 3 Last updated 21 October 2024

What this trial tests

Phase 3 trial testing Ferric carboxymaltose in Surgery in 338 participants. Currently enrolling.

Timeline

4 September 2024

Primary endpoint
31 December 2027

30 March 2028

Quick facts

Lead sponsor	Jon Unosson
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	338
Start date	4 September 2024
Primary completion	31 December 2027
Estimated completion	30 March 2028
Sites	1 location across Sweden

Drugs / interventions tested

• Ferric carboxymaltose (FERRIC CARBOXYMALTOSE) — full drug profile →
• Placebo

Conditions studied

• Surgery — all drugs for Surgery →
• Liver Metastases — all drugs for Liver Metastases →
• Liver Cancer — all drugs for Liver Cancer →
• Pancreas Cancer — all drugs for Pancreas Cancer →

Sponsor

Jon Unosson

Who can join

18 and older, any sex, with Surgery or Liver Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. Median blood loss following hepatopancreatobiliary (HPB) and complex aortic surgery typically range between 500-1000 ml. Bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. For the IRIS trial, it is hypothesized that intravenously (iv) administered Ferric Carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the RBC transfusion.

Patients scheduled for elective HPB surgery or complex aortic surgery will be screened for eligibility and recruited into the study.

By the end of the surgical procedure, if blood loss is estimated to 400-4000 ml, the patient is randomized 1:1 to iv 1000 mg Ferric Carboxymaltose or placebo.

The primary endpoint is a composite of death, number of RBC transfusions, post-operative severe anemia (Hb \<80 g/L) and FACT-An Quality of life (QoL) five weeks after surgery, assessed by win ratio.

The trial will also examine effects on; a) levels of Hb; b) markers of erythropoiesis and iron bioavailability; c) post-operative complications; d) post-operative recovery; e) performance status; f) subgroups based on type of surgery and degree of anemia and iron deficiency; g) re-admissions; h) long term outcome based on patient medical records and i) how post-operative recovery differs between those with low (\<400 ml), high (400-4000 ml) and very high (\>4000 ml) per-operative blood loss.

Recruitment will continue until 338 patients are randomized or 304 have completed the five week follow up

The coordinating center of the trial is the Department of Surgery at Uppsala University Hospital. Participating sites are also Linköping University Hospital and Lund University Hospital, all in Sweden. Other sites may be added.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Inflammatory bowel diseases: pathological mechanisms and therapeutic perspectives.
   Yang X, Guo H, Zou M. · · 2026 · cited 2× · PMID 41495287 · DOI 10.1186/s43556-025-00395-z