Intravenous ferric carboxymaltose (Ferinject®) with or without Erythropoietin for the correction of preoperative anaemia in patients undergoing orthopaedic surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015799-92-AT

Enrollment

Registered

2009-10-14

Start date

2009-12-02

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

• To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status in patients undergoing orthopaedic surgery • To gain informations for the design of a possible follow-up study • . • To evaluate the tolerability and safety of Ferinject®

Interventions

Trade Name: Ferinject Product Name: Ferinject Product Code: 1-27299 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: EPOETIN BETA CAS Number: 122312-54-3 Concentration unit: U unit(s) Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • > 18 years of age and signed written informed consent • Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery) • 10 g/dl =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Suspicion of iron overload (Ferritin >300 µg/l or/and TSAT>50%) • Active severe infection/inflammation (defined as serum CRP > 20 mg/l) or diagnosed malignancy • Folate-and/or Vitamin B12 deficiency (according to local lab reference range) • Known history of hepatitis B/C or HIV-positive • Liver values 3 times higher than normal • Immunosuppressive or myelosuppressive therapy • A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients. • Pregnancy or lactation • Transfusion within 1 month prior to study inclusion, EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail • Participation in any other therapeutic trial within the previous month • History of thromboembolic events in the family or the patient • Severe peripheral, coronary or carotid artery disease • Bodyweight < 50 kg • Patients not able to understand the German language

Design outcomes

Primary

Measure	Time frame
Main Objective: •To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status in patients undergoing orthopaedic surgery ;Secondary Objective: •To gain informations for the design of a possible follow-up study •To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative Hb levels, iron status, transfusion rate, days until discharge. •To evaluate the tolerability and safety of Ferinject ;Primary end point(s): •Hb increase from baseline till day of surgery	—

Measure

Time frame

Main Objective: •To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status in patients undergoing orthopaedic surgery ;Secondary Objective: •To gain informations for the design of a possible follow-up study •To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative Hb levels, iron status, transfusion rate, days until discharge. •To evaluate the tolerability and safety of Ferinject ;Primary end point(s): •Hb increase from baseline till day of surgery

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026