Health TrialsbyHealthPanel

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

ConditionsSurgeryLiver MetastasesLiver CancerPancreas CancerAortic Aneurysm
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJon Unosson

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of written informed consent

Male and female patients

Weight > 50 kg

> 18 years of age

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ferric carboxymaltose

    Drug

    Active drug

  • Placebo

    Drug

    Placebo

Treatment groups

338 Participants
are divided into 2 treatment groups
Group A: Iv IronExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recovery after iv Iron

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 RBC transfusions, prevalence of post-operative severe anaemia (Hb \< 80 g/L) and change in FACT-An QoL questionnaire score at five weeks after surgery compared to pre-operative baseline score. The composite endpoint is assessed by win ratio in the following order: Alive at five weeks (yes/no); number of RBC transfusions from surgery until five weeks; severe anaemia with Hb \<80 g/L any time after surgery until five weeks (yes/no); FACT-An score (score at five weeks minus score at baseline)

Time frame
Five weeks

Secondary outcomes

1

Hb

Assess if effects of the intervention are linked to increased post operative Hb (g/L)

Time frame
One to five weeks
2

Complications

To assess if the intervention reduce post operative complications measured by the comprehensive complication index

Time frame
One to five weeks
3

Recovery

To assess if the intervention affect recovery measured by the post operative morbidity survey

Time frame
One to five weeks
4

Performance status

To assess if the intervention affect performance assessed by Karnofsky performance status

Time frame
Five weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jon Unosson

Lead sponsor

Uppsala University Hospital

Sponsor institution

Source ClinicalTrials.gov
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