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Efficacy and Safety of Monofer (Iron Isomaltate) in the Treatment of postoperative anemia in patients with Spinal Metastasis: a Randomized, controlled, open-label Clinical trial

Efficacy and Safety of Monofer (Iron Isomaltate) in the Treatment of postoperative anemia in patients with Spinal Metastasis: a Randomized, controlled, open-label Clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074150
Enrollment
Unknown
Registered
2023-07-31
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

spinal metastases patients with iron deficiency anemia after operation

Interventions

The treatment group:Iron isomaltoside on the third postoperative day (according to the recommendations of the drug manufacturer), and the maximum dose of iron isomaltoside was limited to 20mg/Kg.
The control group:Ferrous succinate tablets 200mg bid on the third day after operation, a total of 400mg per day, continuous oral administration for 28 days.

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Written informed consent can be signed. 2. Age =18 years old. 3. Malignant tumors confirmed by pathology, and spinal metastasis was suggested by X-ray, CT or magnetic resonance imaging. 4, At least one spinal metastatic lesion requiring surgical intervention: accompanied by malignant pain, spinal instability, spinal cord compression. 5. The function of organs other than organs involved by malignant tumor was good, and the Eastern Cooperative Oncology Group (ECOG) score was 0-2. 6. The expected survival time was =3 months. 7.preoperative hemoglobin =9g/dL, postoperative hemoglobin 7-11g/dL or preoperative and postoperative hemoglobin difference > 2g/dL. 8. drainage =200ml/ day.

Exclusion criteria

Exclusion criteria: 1. Spinal metastases from primary spinal tumors or malignant tumors not confirmed by pathology. 2. Hematological malignancies involving the spine: leukemia, lymphoma, multiple myeloma, etc. 3. Iron metabolism disorders, hemolytic anemia. 4. Allergic diseases and history of iron drug allergy. 5. Liver cirrhosis, alanine aminotransferase or aspartate aminotransferase > 80IU/L. 6. Systemic lupus erythematosus, rheumatic diseases. 7. Infectious diseases. 8. History of blood transfusion within 1 month, pregnancy, radiotherapy and chemotherapy. 9. Refuse to participate.

Design outcomes

Primary

MeasureTime frame
hemoglobin;

Secondary

MeasureTime frame
Reticulocyte count;Reticulocyte hemoglobin content;Serum ferritin;Transferrin saturation;Serum phosphorus;

Countries

China

Contacts

Public ContactBo Li

Shanghai Changzheng Hospital

Liboczspine@smmu.edu.cn+86 175 2165 3448

Outcome results

None listed

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