Cross Iron (Comparative Randomized Oral Versus Systemic IRON)
Status:
Completed
Trial end date:
2016-10-16
Target enrollment:
Participant gender:
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.