Postoperative Replacement of Intraoperative Iron Losses

NCT03680456 | Completed Phase 4

• 1 other identifier: TPL107
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Loss Anemia

Keywords

Anemia; Ferric carboxymaltose; intravenous iron; intraoperative blood loss; patient blood management; Red blood cell transfusion; postoperative iron replacement

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Level

  Hemoglobin in g/dl

  30days

Secondary Outcomes (7)

• Number of RBCs

  30days

• 10 Feet Walking test

  day 7 and 30 post randomization

• 6min Walking Test

  preoperative day, day 7 and 30

• Infection

  30 Days

• MI

  30days

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Drug: Ferric carboxymaltose

Placebo

PLACEBO COMPARATOR

Natriumchlorid is the placebo

Drug: Crystalloid

Interventions

Ferric carboxymaltose DRUG

maximum of 750mg in U.S. is given, maximum of 1000mg in EU

Also known as: Ferinject

Intervention

Crystalloid DRUG

an equivalent volume dose of Natriumchlorid is administered

Also known as: Natriumchlorid

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kepler University Hospital: lead

Study Sites (1)

Universitätsklinik für Anästhesie und Intensivmedizin

Linz, Austria

Location

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose; Crystalloid Solutions; Sodium Chloride

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jens Meier, Prof

  Kepler University Hospital, JKU Linz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: interventional randomized doubleblind, Placebo controlled

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 21, 2018
• Study Start: March 6, 2020
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)