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Ferric Carboxymaltose (FCM) for the Treatment of Anemia Following Total Hip Arthroplasty: A Single-Center, Randomized, Open-Label, Placebo-Controlled Superiority Study

Ferric Carboxymaltose (FCM) for the Treatment of Anemia Following Total Hip Arthroplasty: A Single-Center, Randomized, Open-Label, Placebo-Controlled Superiority Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115823
Enrollment
Unknown
Registered
2025-12-31
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Total hip replacement

Interventions

FCM Group:Postoperative use of FCM injection
Blank control group:Do not use FCM injection solution.

Sponsors

Changzhou Second People's Hospital Affiliated to Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years; 2. Planned to undergo elective, primary unilateral THA; 3. Postoperative days 1–3 diagnosed with anemia: Hb levels meet the specified criteria (men Hb <130 g/L, non-pregnant women Hb <120 g/L); 4. Preoperative iron status: no restrictions but baseline transferrin levels are recorded; 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Known allergy to FCM or any of its excipients; 2. Active serious infection (requiring systemic antibiotic treatment); 3. Severe hepatic or renal insufficiency (as defined by laboratory criteria, such as Child-Pugh class C, eGFR < 30 ml/min/1.73m^2); 4. End-stage renal disease requiring dialysis; 5. Known hemochromatosis or other iron overload disorders; 6. Active malignant tumors (excluding non-melanoma skin cancer); 7. Planned surgery within 42 days postoperatively that may significantly affect Hb levels; 8. Preoperative diagnosis of anemia with prior intravenous iron treatment (preoperative oral iron may be allowed but must be documented); 9. Treatment with erythropoiesis-stimulating agents (ESA) within a specified period before enrollment; 10. Pregnant or breastfeeding women; 11. Investigator judgment of unsuitability for study participation (e.g., severe mental illness, expected poor compliance, life expectancy < 6 months).

Design outcomes

Primary

MeasureTime frame
Hemoglobin;Serum ferritin;

Countries

China

Contacts

Public ContactShang Jingjing

The Affiliated Changzhou Second People’s Hospital of Nanjing Medical University

shang0308@126.com+86 139 2103 2480

Outcome results

None listed

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