Postoperative Replacement of Intraoperative Iron Losses

• Status: Not yet recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kepler University Hospital
• Treatments: Iron

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