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The effect of preoperative intravenous ferric derisomaltose and EPO and tranexamic acid versus usual treatment in patients with preoperative anemia or iron deficiency in bone tumor: a single-center, prospective, open-label, RCT study

The effect of preoperative intravenous ferric derisomaltose and EPO and tranexamic acid versus usual treatment in patients with preoperative anemia or iron deficiency in bone tumor: a single-center, prospective, open-label, RCT study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108117
Enrollment
Unknown
Registered
2025-08-25
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

anaemia

Interventions

Test group:intravenous isomaltose iron combined with erythropoietin and tranexamic acid
Control group:conventional treatment

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 and above with primary malignant bone tumors and bone metastases who plan to undergo open surgery for the sacrum, pelvis, and spine; 2.5 ± 2 days before surgery, hemoglobin<130g/L, or iron deficiency (TSAT<20%); 3.Patients are able to understand the research content and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Ferritin > 800 ng/ml or hemoglobin < 70g/L; 2. Expected survival time is less than six months; 3. Women who are pregnant, breastfeeding or planning to become pregnant; 4. Known allergic reactions to other iron agents; 5. Severe myelosuppressive events (4th degree myelosuppression) 4 weeks before enrollment; 6. Decompensated period of liver disease; 7. Patients with acute infection; 8. Chronic kidney disease stage 3-5; 9. Patients who received oral iron, intravenous iron, EPO, or blood transfusion therapy within 1 month before the start of the study; 10. Other conditions that the investigator considers unsuitable for participating in this study, such as deafness, Parkinson's disease, communication disorders, etc.; 11. Participated in other clinical trials within three months before participating in this study.

Design outcomes

Primary

MeasureTime frame
Hemoglobin level 21 days after surgery;

Secondary

MeasureTime frame
Blood transfusion rate and volume within 21 days after surgery;Hemoglobin levels 7 and 14 days after surgery;Proportion of iron deficiency on postoperative days 7, 14, and 21;

Countries

China

Contacts

Public ContactTang Xiaodong

Peking University People's Hospital

ttang15877@126.com+86 138 0111 9367

Outcome results

None listed

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