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

NCT07057973 | Recruiting

• 1 other identifier: Xuanwu_DLD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. International studies provide high-level evidence-based evidence for intravenous iron, but lack spinal surgery-specific data; domestic studies focus on the comparison of iron types and the improvement of clinical practice, but high-quality evidence is still insufficient. At present, there are still few studies on preoperative iron therapy in the field of spinal surgery, especially its specific impact on the prognosis of patients after lumbar fusion surgery is still unclear. Therefore, it is particularly important to study the preoperative iron supplementation regimen for lumbar fusion surgery to improve the efficacy and safety. Through multidisciplinary collaboration and technological innovation, preoperative iron therapy is expected to become an important part of accelerated recovery after lumbar fusion surgery.

Conditions

Ferric Carboxymaltose

Outcome Measures

Primary Outcomes (2)

• the levels of hemoglobin

  the levels of hemoglobin

  on the first, fourth, and seventh days after surgery and at four weeks

• the level of iron metabolism indicators (serum iron, ferritin, transferrin, and transferrin saturation)

  the level of iron metabolism indicators (serum iron, ferritin, transferrin, and transferrin saturation)

  on the first, fourth, and seventh days after surgery and at 4 weeks

Study Arms (2)

Control group

NO INTERVENTION

Placebo treatment

Ferric carboxymaltose

EXPERIMENTAL

Ferric carboxymaltose treatment

Drug: Ferric carboxymaltose

Interventions

Ferric carboxymaltose DRUG

The experimental group was treated with 1000 mg of ferric carboxymaltose

Ferric carboxymaltose

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 10053, China

RECRUITING

MeSH Terms

Interventions

ferric carboxymaltose

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)