Postoperative replacement of iron losses happening during and after an operatio

Phase 1

Conditions: perioperative bleeding induced iron losses and anemia
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2018-003184-65-AT

Lead Sponsor: Vifor Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 360

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

• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): -number of transfusions<br>-number of perioperative infections, death, myocardial infarction, acute kidney injury, stroke<br>-ability to walk 10 feet at day 7 and 30 post randomization<br>-6min walkin Test at day 7 and 30<br>-iron profiles (serum iron, iron binding capacity);Timepoint(s) of evaluation of this end point: 30 days