Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation
Overview
- Phase
- Not Applicable
- Intervention
- ferrous glycine sulfate Tardyferon
- Conditions
- Allogenic Transfusion
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1: Per Os 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).
Intervention: ferrous glycine sulfate Tardyferon
Group 1: Per Os 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).
Intervention: Epoetin Alfa
Group 2: IV 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.
Intervention: Epoetin Alfa
Group 2: IV 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.
Intervention: ferric carboxymaltose Ferinject
Outcomes
Primary Outcomes
Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route
Time Frame: the day before surgery (day - 1)
Secondary Outcomes
- 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))