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Postoperative Replacement of Intraoperative Iron Losses

NCT03680456 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-02-04

No results posted yet for this study

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

Interventions

DRUG

Ferric carboxymaltose

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

DRUG

Crystalloid

an equivalent volume dose of Natriumchlorid is administered

Sponsors & Collaborators

  • Kepler University Hospital

    lead OTHER

Principal Investigators

  • Jens Meier, Prof · Kepler University Hospital, JKU Linz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03680456 on ClinicalTrials.gov