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Postoperative Replacement of Intraoperative Iron Losses (POREIIL)

Primary Purpose

Blood Loss Anemia

Status
Recruiting
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Ferric carboxymaltose
Crystalloid
Sponsored by
Kepler University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss Anemia focused on measuring Anemia, Ferric carboxymaltose, intravenous iron, intraoperative blood loss, patient blood management, Red blood cell transfusion, postoperative iron replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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):

    - 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Universitätsklinik für Anästhesie und IntensivmedizinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

due to postoperative Hemoglobin Level intravenous iron Ferriccarboxymaltose is Infuses, dosage is based on the Ganzoni-Algorithm

Natriumchlorid is the placebo

Outcomes

Primary Outcome Measures

Hemoglobin Level
Hemoglobin in g/dl

Secondary Outcome Measures

Number of RBCs
Number of Units of Red Blood Cell transfusions
10 Feet Walking test
ability to walk 10 feet or across the room
6min Walking Test
The distance ist measured which the Patient is able to walk in 6 min
Infection
Number of severe Sepsis or wound infection due to SSC Guidelines and Sofa-Score
MI
myocardial infarction is diagnosed du to ECG, Troponin T and clinical signs and symptoms for myocardial infarction e.g. chest pain
AKI
acute kidney injury due to KDIGO criteria
Stroke
numbers of stroke (e.b. subarachnoid hemorrhage and others)

Full Information

First Posted
September 20, 2018
Last Updated
March 30, 2022
Sponsor
Kepler University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03680456
Brief Title
Postoperative Replacement of Intraoperative Iron Losses
Acronym
POREIIL
Official Title
Postoperative Replacement of Intraoperative Iron Losses
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kepler University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss Anemia
Keywords
Anemia, Ferric carboxymaltose, intravenous iron, intraoperative blood loss, patient blood management, Red blood cell transfusion, postoperative iron replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
interventional randomized doubleblind, Placebo controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
due to postoperative Hemoglobin Level intravenous iron Ferriccarboxymaltose is Infuses, dosage is based on the Ganzoni-Algorithm
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Natriumchlorid is the placebo
Intervention Type
Drug
Intervention Name(s)
Ferric carboxymaltose
Other Intervention Name(s)
Ferinject
Intervention Description
maximum of 750mg in U.S. is given, maximum of 1000mg in EU
Intervention Type
Drug
Intervention Name(s)
Crystalloid
Other Intervention Name(s)
Natriumchlorid
Intervention Description
an equivalent volume dose of Natriumchlorid is administered
Primary Outcome Measure Information:
Title
Hemoglobin Level
Description
Hemoglobin in g/dl
Time Frame
30days
Secondary Outcome Measure Information:
Title
Number of RBCs
Description
Number of Units of Red Blood Cell transfusions
Time Frame
30days
Title
10 Feet Walking test
Description
ability to walk 10 feet or across the room
Time Frame
day 7 and 30 post randomization
Title
6min Walking Test
Description
The distance ist measured which the Patient is able to walk in 6 min
Time Frame
preoperative day, day 7 and 30
Title
Infection
Description
Number of severe Sepsis or wound infection due to SSC Guidelines and Sofa-Score
Time Frame
30 Days
Title
MI
Description
myocardial infarction is diagnosed du to ECG, Troponin T and clinical signs and symptoms for myocardial infarction e.g. chest pain
Time Frame
30days
Title
AKI
Description
acute kidney injury due to KDIGO criteria
Time Frame
30 days
Title
Stroke
Description
numbers of stroke (e.b. subarachnoid hemorrhage and others)
Time Frame
30days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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): - 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roxane Brooks, Dr.
Phone
00435768083
Ext
78148
Email
roxane.brooks@kepleruniklinikum.at
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Meier, Prof
Phone
00435768083
Ext
2158
Email
jens.meier@kepleruniklinikum.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Meier, Prof
Organizational Affiliation
Kepler University Hospital, JKU Linz
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinik für Anästhesie und Intensivmedizin
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Meier, MD
Email
jens.meier@kepleruniklinikum.at
First Name & Middle Initial & Last Name & Degree
Bernhard Eichler, MD
First Name & Middle Initial & Last Name & Degree
Roxanne Brooks, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Replacement of Intraoperative Iron Losses

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