SurgeryPhase 3IRISNCT05744219
Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial
A Phase 3 study testing Ferric carboxymaltose in people with Surgery and Liver Metastases, run by Jon Unosson at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Liver Metastases, Liver Cancer
- What is being tested?
- Ferric carboxymaltose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 1 siteSweden
- Study dates
- 4 Sep 2024to 30 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, Sverige
Jon Unosson
About this study
Official title: Improved Recovery by Iron Following Surgery With Blood Loss, a Double-blind Multi-centre Randomized Controlled Phase III Drug Trial (the IRIS-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.
Read more
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.
- Conditions
- Surgery, Liver Metastases, Liver Cancer, Pancreas Cancer, Aortic Aneurysm
- Being tested
- Ferric carboxymaltose, Placebo
- Medical subject headings
- Liver Neoplasms, Pancreatic Neoplasms, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Active drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Iv Iron | Experimental | Ferric Carboxymaltose, single dose, Intra venous 1000 mg in 100 ml 0.9% NaCl Receives: Drug: Ferric carboxymaltose |
| Placebo | Placebo comparator | Placebo, single dose, Intra venous 0.9% NaCl 100 ml Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Five weeks
Secondary outcomes (4)
Hb
Assess if effects of the intervention are linked to increased post operative Hb (g/L)
Measured: One to five weeks
Complications
To assess if the intervention reduce post operative complications measured by the comprehensive complication index
Measured: One to five weeks
Recovery
To assess if the intervention affect recovery measured by the post operative morbidity survey
Measured: One to five weeks
Performance status
To assess if the intervention affect performance assessed by Karnofsky performance status
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start4 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jon Unosson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jon Unosson, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744219
- Sponsor's protocol ID
- IRIS
- Acronym
- IRIS
- Status last verified
- Oct 2024
- First submitted
- 6 Feb 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: May be available on request
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Recovery by Iron Following Surgery With Blood Loss, a Double-blind Multi-centre Randomized Controlled Phase III Drug Trial (the IRIS-trial)
- ClinicalTrials.gov ID
- NCT05744219
- Acronym / sponsor ID
- IRIS / IRIS
- Conditions
- Surgery, Liver Metastases, Liver Cancer, Pancreas Cancer, Aortic Aneurysm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Jon UnossonUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Iv Iron | Experimental | Drug: Ferric carboxymaltoseFerric Carboxymaltose, single dose, Intra venous 1000 mg in 100 ml 0.9% NaCl |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, single dose, Intra venous 0.9% NaCl 100 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltoseActive drug | Drug | Iv Iron |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Recovery after iv Iron
Time frame: Five weeks
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)
4 secondary outcomes
Hb
Time frame: One to five weeks
Complications
Time frame: One to five weeks
Recovery
Time frame: One to five weeks
Performance status
Time frame: Five weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No. May be available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric carboxymaltose in people with Surgery and Liver Metastases, run by Jon Unosson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jon Unosson, MDPhD (+46186110000, jon.unosson@surgsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery after iv Iron (time frame: Five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.