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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2028-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy

NCT02628860

Pancreatic Cancer Anemia

COMPLETED PHASE2

Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma

NCT00149565

Hepatocellular Carcinoma

COMPLETED PHASE3

Single-arm Clinical Trial of TACE in Combination With Icaritin as Adjuvant Therapy After Surgery in Patients With Hepatocellular Carcinoma at High Risk of Recurrence

NCT06644937

Hepatocellular Carcinoma (HCC)

RECRUITING PHASE2/PHASE3

Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy

NCT04246021

Anemia Cancer

COMPLETED NA

Efficacy and Safety of Icaritin Combined With mFOLFOX in Postoperative HCC With High-risk Recurrence Factors

NCT07337460

Hepatocellular Carcinoma (HCC)

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery Liver Metastases Liver Cancer Pancreas Cancer Aortic Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

At end of surgery, peri-operative blood loss is determined and if 400-4000 ml, the patient is randomised to iv Ferric Carboxymaltose 1000 mg or placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The attending nurse at the postoperative ward will do the final preparation of study drug and thus be aware of which patient receives placebo or iv iron. As the Ferric Carboxymaltose solution is opaque, the study drug is kept concealed behind the patient. Most patients have amnesia of the first hours after general anaesthesia. This effect is more pronounced after long and complex surgery which is the case for all patients included in this trial. Blinding from the patent's perspective is therefore not expected to be a major concern. The personnel preparing the study drug and nurse at the postoperative ward does not participate in care beyond this point, ensuring blinding is maintained.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iv Iron

Ferric Carboxymaltose, single dose, Intra venous 1000 mg in 100 ml 0.9% NaCl

Group Type EXPERIMENTAL

Ferric carboxymaltose

Intervention Type DRUG

Active drug

Placebo

Placebo, single dose, Intra venous 0.9% NaCl 100 ml

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ferric carboxymaltose

Active drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Provision of written informed consent
2. Male and female patients
3. Weight \> 50 kg
4. \> 18 years of age
5. Scheduled for complex aortic surgery, liver resection or pancreatic resection

Exclusion Criteria

1. Short expected survival (less than six months)
2. Intra-venous iron therapy within one month prior to surgery
3. Severe anaemia (B-Hb \<80 mg/L) prior to surgery
4. Contraindication to Ferric Carboxymaltose according to SmPC
5. Iron overloading disorder, i.e. hemochromatosis
6. Risk of small for size future liver remnant
7. Pre-operative renal replacement therapy
8. Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study
9. Another planned major surgical procedure before the five week follow up
10. Unsuitable for inclusion according to the investigator
11. Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No