perioperative bleeding induced iron losses and anemia
Conditions
Interventions
Trade Name: Ferinject
Product Name: Ferinject
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Other descriptive name: Eisen(
Sponsors
Vifor Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • patients undergoing non-emergency - cardiac surgery - intra-abdominal surgery • preoperative Hb (during the premedication visit): -male: Hb>12.5g/dl -female: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
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 • pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: not applicable;Primary end point(s): Hemoglobin concentration at 30th day following surgery;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -number of transfusions -number of perioperative infections, death, myocardial infarction, acute kidney injury, stroke -ability to walk 10 feet at day 7 and 30 post randomization -6min walkin Test at day 7 and 30 -iron profiles (serum iron, iron binding capacity);Timepoint(s) of evaluation of this end point: 30 days | — |
Countries
Austria, United States
Contacts
Public ContactHead Medical AT
Vifor Pharma
Outcome results
None listed