The Effect of Preoperative Intravenous Ferric Derisomaltose and EPO and Tranexamic Acid in Patients With Preoperative Anemia or Iron Deficiency in Bone Tumor

The pelvis and spine are common sites of primary and secondary bone tumors, and most patients require surgical treatment. However, due to bleeding, high tumor burden, and other reasons, iron deficiency anemia (IDA) is common in these patients. At present, allogeneic blood resources are scarce in China and even globally, and cancer patients cannot undergo autologous blood transfusion. In addition, there is a large amount of bleeding during pelvic and spinal open surgery, which collectively leads to a high incidence of perioperative anemia in patients with pelvic and spinal tumors, and even the loss of surgical opportunities. Therefore, perioperative blood management for bone tumor surgery is extremely important. The combination of intravenous iron and EPO has been proven to rapidly improve the hemoglobin levels of perioperative surgical patients in previous studies, but there is currently no research related to bone tumors. This study uses a single center, prospective, open label, randomized controlled clinical trial to explore the effects of preoperative application of intravenous isomaltose iron combined with erythropoietin and tranexamic acid compared to conventional treatment in patients with preoperative anemia or iron deficiency in bone tumor surgery, hoping to establish a standard paradigm for perioperative blood management in bone tumor patients.

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Key information

Conditions

Anemia Bone Diseases Bone Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
5 ± 2 days before surgery, hemoglobin<130g/L, or iron deficiency (TSAT<20%)
Patients are able to understand the research content and sign informed consent forms

Exclusion criteria

Meet any of the following criteria;

Ferritin>800 ng/ml or hemoglobin<70 g/L
Expected survival period less than six months
Women who are pregnant, breastfeeding, or planning to conceive
Known to have allergic reactions to other iron agents
Severe bone marrow suppression event (4th degree bone marrow suppression) occurred 4 weeks before enrollment
Decompensated stage of liver disease
Patients with combined acute phase infections
Chronic kidney disease stage 3-5
Patients who received oral iron, intravenous iron, EPO, or blood transfusion treatment within one month prior to the start of the study.
Researchers believe that other conditions that are not suitable for participation in this study, such as deafness, Parkinson's disease, communication disorders, etc
Participated in other clinical trials within the three months prior to participating in this study

Treatment and study plan

isomaltose iron

Drug

Calculate the patient's iron requirement based on a simplified scale for the isomaltose iron group; Yibiao 150IU/kg subcutaneous injection, no treatment in the conventional treatment group; 0.5g of tranexamic acid is administered locally after dilution before surgical closure

Primary outcomes

Hb levels 21 days after surgery

Time frame: Day 21

Secondary outcomes

Blood transfusion rate within 21 days after surgery

Time frame: Day 21
Hb levels 14 days after surgery

Time frame: Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Tang Xiaodong

CONTACT

[email protected]

010-88326196

Sponsors and collaborators

Lead sponsor

Tang Xiaodong

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 2, 2026
Registry last updated: Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed