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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Austria1 site
  • Universitätsklinik für Anästhesie und Intensivmedizin

    Linz

Other trials in Austria

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.

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 groups in NCT03680456
Study groupRoleWhat they receive
InterventionActive comparatordue to postoperative Hemoglobin Level intravenous iron Ferriccarboxymaltose is Infuses, dosage is based on the Ganzoni-Algorithm
Receives: Drug: Ferric carboxymaltose
PlaceboPlacebo comparatorNatriumchlorid is the placebo
Receives: Drug: Crystalloid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin Level

    Hemoglobin in g/dl

    Measured: 30days

Secondary outcomes (7)
  1. Number of RBCs

    Number of Units of Red Blood Cell transfusions

    Measured: 30days

  2. 10 Feet Walking test

    ability to walk 10 feet or across the room

    Measured: day 7 and 30 post randomization

  3. 6min Walking Test

    The distance ist measured which the Patient is able to walk in 6 min

    Measured: preoperative day, day 7 and 30

  4. Infection

    Number of severe Sepsis or wound infection due to SSC Guidelines and Sofa-Score

    Measured: 30 Days

  5. MI

    myocardial infarction is diagnosed du to ECG, Troponin T and clinical signs and symptoms for myocardial infarction e.g. chest pain

    Measured: 30days

  6. AKI

    acute kidney injury due to KDIGO criteria

    Measured: 30 days

  7. 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.

  1. First posted21 Sep 2018
  2. Study start6 Mar 2020
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Resources

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)
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

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.

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