Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

Not Applicable

Completed

• Conditions: Allogenic Transfusion; Perioperative Anaemia; Knee Arthroplasty; Hip Arthroplasty
• Interventions: Drug: ferrous glycine sulfate Tardyferon; Drug: Epoetin Alfa; Drug: ferric carboxymaltose Ferinject

• Registration Number: NCT02496377
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-29
• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Primary Completion: 2016-10-16
• Study Completion: 2016-10-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Per Os Tardyferon	ferrous glycine sulfate Tardyferon	EPO associated with Iron per os tardyferon before surgery. 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).
Group 1: Per Os Tardyferon	Epoetin Alfa	EPO associated with Iron per os tardyferon before surgery. 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).
Group 2: IV Ferinject	Epoetin Alfa	EPO associated with Iron per IV Ferinject before surgery. The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections.
Group 2: IV Ferinject	ferric carboxymaltose Ferinject	EPO associated with Iron per IV Ferinject before surgery. The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections.

Primary Outcome Measures

Name	Time	Method
Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route	the day before surgery (day - 1)

Secondary Outcome Measures

Name	Time	Method
Hb level	before iron treatment, then the day before surgery (day - 1) based on reference iron balance
number of red blood cells	during surgery and 3 days after surgery
the change in iron indices	before iron treatment and after iron treatment the day before surgery (day - 1)

Trial Locations

Locations (1)

Hôpital Lapeyronie - Département Anesthésie Réanimation A; 🇫🇷 Montpellier, France