NCT02496377

Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allogenic Transfusion
• Perioperative Anaemia
• Knee Arthroplasty
• Hip Arthroplasty

Interventions

Type	Name	Description
DRUG	ferrous glycine sulfate Tardyferon
DRUG	Epoetin Alfa
DRUG	ferric carboxymaltose Ferinject

Timeline

• Start date: 2014-08-29
• Primary completion: 2016-10-16
• Completion: 2016-10-16
• First posted: 2015-07-14
• Last updated: 2019-01-23

Locations

1 site across 1 country: France