Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

• Status: Completed
• Trial end date: 2016-10-16
• Target enrollment: 0
• Participant gender: All

Summary

Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Epoetin Alfa; Ferric Compounds; Glycine; Iron

Criteria

Inclusion criteria:

• unilateral prothetic orthopaedic surgery scheduled

• age > 18

• weight > 50 kg

• hemoglobin rate: 10 g/dl ≤ Hb <13 g/dl

Exclusion criteria:

• bilateral arthroplasty

• EPO contraindication

• generalized infection