Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

University Hospital Center (CHU)

Status: Completed

Conditions: Knee Arthroplasty; Perioperative Anaemia; Allogenic Transfusion; Hip Arthroplasty

Treatments: Drug: Epoetin Alfa; Drug: ferrous glycine sulfate Tardyferon; Drug: ferric carboxymaltose Ferinject

Study type: Interventional

Funder types: Other

Identifiers

NCT02496377

9408

2014-A00642-45 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group 1: Per Os Tardyferon

Active Comparator group

Description:

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).

Treatment:

Drug: ferrous glycine sulfate Tardyferon

Drug: Epoetin Alfa

Group 2: IV Ferinject

Experimental group

Description:

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.

Treatment:

Drug: ferric carboxymaltose Ferinject

Drug: Epoetin Alfa