Preoperative ferric carboxymaltose to improve anemia before multi-level lumbar fusion in older adults

The Effectiveness of Preoperative Iron Therapy in Improving Anemia After Multi-level Lumbar Fusion in the Elderly

This trial will test whether giving intravenous ferric carboxymaltose before multi-level lumbar fusion helps older adults with iron-deficiency anemia raise their hemoglobin, reduce complications, and improve recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 60 Years to 90 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07057973 on ClinicalTrials.gov

What this trial studies

This interventional single-center study at Xuanwu Hospital will give preoperative ferric carboxymaltose to patients aged 65 or older with iron-deficiency anemia scheduled for multi-level lumbar fusion and measure hemoglobin and iron indices on postoperative days 1, 4, and 7. Outcomes include perioperative hemoglobin and iron metabolism markers, 90-day adverse events, and health-related quality of life indicators. Key exclusions include allergy to IV iron, decompensated cirrhosis, microcytic anemia, prior spinal tumor/trauma/infection, inflammatory or immune diseases, and incomplete clinical data. The trial aims to define an optimized preoperative iron supplementation regimen specific to spinal fusion to support faster and safer recovery in the elderly.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 or older with iron-deficiency anemia (male Hb < 120 g/L, female Hb < 110 g/L) who are scheduled for multi-segment lumbar fusion and can complete required questionnaires and follow-up.

Not a fit: Patients with decompensated cirrhosis, microcytic anemia, a history of allergy to ferric carboxymaltose or other IV iron, prior spinal tumor/trauma/infection, active inflammatory/immune disease, or age under 65 are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, preoperative ferric carboxymaltose could reduce postoperative anemia and transfusions, lower complication rates, and speed recovery after multi-level lumbar fusion in older adults.

How similar studies have performed: Intravenous iron has been shown to reduce transfusion needs and improve hemoglobin in other surgical populations, but high-quality, spine-specific evidence remains limited.

Eligibility criteria

Inclusion Criteria:

* All patients underwent multi-segment lumbar spine surgery;
* IDA patients aged 65 years or older (male: Hb \< 120g/dL; female: Hb \< 110g/dL);
* All patients completed the relevant questionnaire survey;

Exclusion Criteria:

* Age less than 65 years old;
* Previous surgery for spinal tumors, trauma or infection;
* Inflammatory or immune diseases (such as rheumatoid arthritis or systemic lupus erythematosus), acute kidney injury, progressive cancer and porphyria cutanea tarda);
* Non-adjacent segment surgery;
* History of allergy to ferric carboxymaltose or any intravenous iron preparations, asthma, atopic dermatitis or allergy;
* Decompensated cirrhosis and microcytic anemia;
* Incomplete clinical data;

Where this trial is running

Beijing, Beijing Municipality

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Conditions Ferric Carboxymaltose