Blood Loss AnemiaPhase 4POREIILNCT03680456
Postoperative Replacement of Intraoperative Iron Losses
A Phase 4 study testing Ferric carboxymaltose and Crystalloid in people with Blood Loss Anemia, run by Kepler University Hospital at 1 site in Austria.
Trial summary
By performing a randomized, blinded placebo controlled exploratory trial we speculate that replacement of perioperative, bleeding-induced iron losses with ferric carboxymaltose immediately after the surgical procedure can replenish iron with increased hemoglobin levels and reduce the amount of pRBCs transfused in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss Anemia
- What is being tested?
- Ferric carboxymaltose and Crystalloid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteAustria
- Study dates
- 6 Mar 2020to 31 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- patients undergoing non-emergency
- cardiac surgery - obstetric surgery - intra-abdominal surgery
- preoperative Hb (during the premedication visit):
- ♂: Hb>12.5g/dl
- ♀: Hb>11.5g/dl
- postoperative Hb (immediately after surgical procedure in the recovery room):
Show all 10Show fewer
- 2 g/dl below preoperative Hb concentration
- age ≥ 18 years
- Admission to intensive care unit or post-anesthesia care unit
- Able to sign consent for the trial
Who cannot join
- age < 18 years
- emergency surgery
- perioperative application of iron and/or erythropoietin
- intraoperative transfusion of allogeneic erythrocytes
- known hemochromatosis
- known allergic reaction linked to iron medication
Trial locations and contacts
1 site in 1 country.
About this study
By performing a randomized, blinded placebo controlled exploratory trial we speculate that replacement of perioperative, bleeding-induced iron losses with ferric carboxymaltose immediately after the surgical procedure can replenish iron with increased hemoglobin levels and reduce the amount of pRBCs transfused in the postoperative period (30 days post surgery).
Read the detailed description
In the last few years, state of the art Patient Blood Management (PBM programs have been gaining worldwide attention. This may be attributed to the significant improvements in patient outcomes that follow adequate preoperative preparation and intraoperative optimization of the circulating red cell mass.
The first pillar of PBM (pre-, intra-, and postoperative optimization of red cell mass by means other than red cell transfusions including intravenous iron and erythropoietin stimulating agents) can meet significant barriers and might be difficult to implement. In daily clinical practice, timely identification and treatment of preoperative anemia is difficult to organize due to structural and behavioral constraints. Therefore, today, there are still a striking number of patients who are admitted for surgery without adequate preoperative treatment of anemia regardless of its causes. Notably, even for this patient population, it has been demonstrated by experimental and larger observational data that postoperative application of intravenous iron could help to reduce perioperative transfusions by restoring red cell mass. The complete potential of perioperative intravenous iron therapy has yet to identified, including improvements such as early mobility and other improved outcomes. Furthermore, a substantial number of patients are not included in preoperative red cell mass optimization, since the preoperative hemoglobin concentration is either high enough in terms of the thresholds of the World Health Organization (♂ 13 g/dl and ♀ 12 g/dl), or borderline (mild) anemia is diagnosed and no treatment is offered. These patients may be prone to substantial intraoperative blood losses, and as a consequence might suffer from postoperative iron restricted anemia. In fact, there are a remarkable number of patients that have adequate hemoglobin concentrations preoperatively, but ultimately develop anemia with iron deficiency postoperatively due to significant intraoperative bleeding. Data from ICU patients' with postoperative iron deficiency has significant impact on outcome including postoperative fatigue, and consequently a prolonged healing process.
Although this problem is common, current PBM strategies are in need of validation of one of the PBM guidelines: postoperative replacement of blood loss with resultant iron losses in patients without preoperative anemia thus avoiding exposure to allogeneic transfusions in this population. The untested hypothesis is that this approach could improve postoperative outcomes including mobilization. Based on a recent publication one might surmise that it is not (only) postoperative anemia, but rather untreated iron deficiency, that is responsible for a delay in postoperative mobilization and recovery. It is therefore the aim of the proposal presented to describe an additional approach, in which perioperative, surgical blood loss iron losses are replaced immediately following the surgical procedure in patients that did not receive iron preoperatively due to normal or minor reduction in hemoglobin concentrations (red cell mass). This replacement may take place in either the postoperative anesthesia care unit or in the ICU, Although preoperative treatment of iron deficiency anemia is widely considered the most important domain of perioperative iron therapy, the additional post-operative replacement is as useful as preoperative preparation and seems to be more convenient to implement.
- Conditions
- Blood Loss Anemia
- Being tested
- Ferric carboxymaltose, Crystalloid
- Keywords
- Anemia, Ferric carboxymaltose, intravenous iron, intraoperative blood loss, patient blood management, Red blood cell transfusion, postoperative iron replacement
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called Ferinject
maximum of 750mg in U.S. is given, maximum of 1000mg in EU
CrystalloidDrug
Also called Natriumchlorid
an equivalent volume dose of Natriumchlorid is administered
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | due to postoperative Hemoglobin Level intravenous iron Ferriccarboxymaltose is Infuses, dosage is based on the Ganzoni-Algorithm Receives: Drug: Ferric carboxymaltose |
| Placebo | Placebo comparator | Natriumchlorid is the placebo Receives: Drug: Crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Level
Hemoglobin in g/dl
Measured: 30days
Secondary outcomes (7)
Number of RBCs
Number of Units of Red Blood Cell transfusions
Measured: 30days
10 Feet Walking test
ability to walk 10 feet or across the room
Measured: day 7 and 30 post randomization
6min Walking Test
The distance ist measured which the Patient is able to walk in 6 min
Measured: preoperative day, day 7 and 30
Infection
Number of severe Sepsis or wound infection due to SSC Guidelines and Sofa-Score
Measured: 30 Days
MI
myocardial infarction is diagnosed du to ECG, Troponin T and clinical signs and symptoms for myocardial infarction e.g. chest pain
Measured: 30days
AKI
acute kidney injury due to KDIGO criteria
Measured: 30 days
Stroke
numbers of stroke (e.b. subarachnoid hemorrhage and others)
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start6 Mar 2020
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- interventional randomized doubleblind, Placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roxane Brooks, Kepler University Hospital
- Investigators
- Jens Meier, Prof, Study director, Kepler University Hospital, JKU Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680456
- Sponsor's protocol ID
- TPL107
- Acronym
- POREIIL
- Status last verified
- Jan 2025
- First submitted
- 20 Sep 2018
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Replacement of Intraoperative Iron Losses
- ClinicalTrials.gov ID
- NCT03680456
- Acronym / sponsor ID
- POREIIL / TPL107
- Conditions
- Blood Loss Anemia
- Keywords
- Anemia, Ferric carboxymaltose, intravenous iron, intraoperative blood loss, patient blood management, Red blood cell transfusion, postoperative iron replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 21 Sep 2018 (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.
By performing a randomized, blinded placebo controlled exploratory trial we speculate that replacement of perioperative, bleeding-induced iron losses with ferric carboxymaltose immediately after the surgical procedure can replenish iron with increased hemoglobin levels and reduce the amount of pRBCs transfused in the postoperative period (30 days post surgery).
Detailed description
In the last few years, state of the art Patient Blood Management (PBM programs have been gaining worldwide attention. This may be attributed to the significant improvements in patient outcomes that follow adequate preoperative preparation and intraoperative optimization of the circulating red cell mass.
The first pillar of PBM (pre-, intra-, and postoperative optimization of red cell mass by means other than red cell transfusions including intravenous iron and erythropoietin stimulating agents) can meet significant barriers and might be difficult to implement. In daily clinical practice, timely identification and treatment of preoperative anemia is difficult to organize due to structural and behavioral constraints. Therefore, today, there are still a striking number of patients who are admitted for surgery without adequate preoperative treatment of anemia regardless of its causes. Notably, even for this patient population, it has been demonstrated by experimental and larger observational data that postoperative application of intravenous iron could help to reduce perioperative transfusions by restoring red cell mass. The complete potential of perioperative intravenous iron therapy has yet to identified, including improvements such as early mobility and other improved outcomes. Furthermore, a substantial number of patients are not included in preoperative red cell mass optimization, since the preoperative hemoglobin concentration is either high enough in terms of the thresholds of the World Health Organization (♂ 13 g/dl and ♀ 12 g/dl), or borderline (mild) anemia is diagnosed and no treatment is offered. These patients may be prone to substantial intraoperative blood losses, and as a consequence might suffer from postoperative iron restricted anemia. In fact, there are a remarkable number of patients that have adequate hemoglobin concentrations preoperatively, but ultimately develop anemia with iron deficiency postoperatively due to significant intraoperative bleeding. Data from ICU patients' with postoperative iron deficiency has significant impact on outcome including postoperative fatigue, and consequently a prolonged healing process.
Although this problem is common, current PBM strategies are in need of validation of one of the PBM guidelines: postoperative replacement of blood loss with resultant iron losses in patients without preoperative anemia thus avoiding exposure to allogeneic transfusions in this population. The untested hypothesis is that this approach could improve postoperative outcomes including mobilization. Based on a recent publication one might surmise that it is not (only) postoperative anemia, but rather untreated iron deficiency, that is responsible for a delay in postoperative mobilization and recovery. It is therefore the aim of the proposal presented to describe an additional approach, in which perioperative, surgical blood loss iron losses are replaced immediately following the surgical procedure in patients that did not receive iron preoperatively due to normal or minor reduction in hemoglobin concentrations (red cell mass). This replacement may take place in either the postoperative anesthesia care unit or in the ICU, Although preoperative treatment of iron deficiency anemia is widely considered the most important domain of perioperative iron therapy, the additional post-operative replacement is as useful as preoperative preparation and seems to be more convenient to implement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- interventional randomized doubleblind, Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Ferric carboxymaltosedue to postoperative Hemoglobin Level intravenous iron Ferriccarboxymaltose is Infuses, dosage is based on the Ganzoni-Algorithm |
| Placebo | Placebo comparator | Drug: CrystalloidNatriumchlorid is the placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- patients undergoing non-emergency
- preoperative Hb (during the premedication visit):
- postoperative Hb (immediately after surgical procedure in the recovery room):
- age ≥ 18 years
- Admission to intensive care unit or post-anesthesia care unit
Key exclusion criteria (6 listed)
- age < 18 years
- emergency surgery
- perioperative application of iron and/or erythropoietin
- intraoperative transfusion of allogeneic erythrocytes
- known 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 carboxymaltoseAlso: Ferinjectmaximum of 750mg in U.S. is given, maximum of 1000mg in EU | Drug | Intervention |
| CrystalloidAlso: Natriumchloridan equivalent volume dose of Natriumchlorid is administered | Drug | Placebo |
Primary outcome
Hemoglobin Level
Time frame: 30days
Hemoglobin in g/dl
7 secondary outcomes
Number of RBCs
Time frame: 30days
10 Feet Walking test
Time frame: day 7 and 30 post randomization
6min Walking Test
Time frame: preoperative day, day 7 and 30
Infection
Time frame: 30 Days
MI
Time frame: 30days
AKI
Time frame: 30 days
Stroke
Time frame: 30days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jens Meier, Prof study director
Kepler University Hospital, JKU Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric carboxymaltose and Crystalloid in people with Blood Loss Anemia, run by Kepler University Hospital at 1 site in Austria.
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 10 inclusion and 6 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: finished, as of the sponsor's last update on 4 Feb 2025. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin Level (time frame: 30days). 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 4 Feb 2025.