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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00642-45 | Registry Identifier | ID RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Per Os Tardyferon | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferrous glycine sulfate Tardyferon | Drug |
| ||
| Epoetin Alfa |
| 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) |
| 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 | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe BIBOULET, MD, PhD | Montpellier University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Lapeyronie - Département Anesthésie Réanimation A | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| C522335 | ferric carboxymaltose |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Drug |
|
| ferric carboxymaltose Ferinject | Drug |
|
| the change in iron indices |
| before iron treatment and after iron treatment the day before surgery (day - 1) |
| D009750 | Nutritional and Metabolic Diseases |
| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |