CompletedPhase 4

Postoperative Replacement of Intraoperative Iron Losses

Austria134 participantsStarted 2020-03-06

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Hemoglobin Level

Timeframe: 30days

Trial details

NCT IDNCT03680456

SponsorKepler University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-31

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