Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

Study Overview
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Brief Summary
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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.

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

Conditions
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Allogenic Transfusion, Perioperative Anaemia, Knee Arthroplasty, Hip Arthroplasty

Intervention / Treatment
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* Drug: ferrous glycine sulfate Tardyferon
* Drug: Epoetin Alfa
* Drug: ferric carboxymaltose Ferinject


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Per Os Tardyferon<br>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). | Drug: ferrous glycine sulfate Tardyferon<br> <br> Drug: Epoetin Alfa<br> <br> |
| Experimental: Group 2: IV Ferinject<br>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. | Drug: Epoetin Alfa<br> <br> Drug: ferric carboxymaltose Ferinject<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaemia, Iron deficiency, Ferric carboxymaltose, Patient blood management, Hip arthroplasty, Knee arthroplasty