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

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia
• Intervention / Treatment: Drug: isomaltose iron

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tang Xiaodong; Phone Number: 010-88326196; Email: tang15877@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isomaltose Anhydride Iron Group; 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	Drug: isomaltose iron; 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
No Intervention: Conventional treatment group; Traditional symptomatic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hb levels 21 days after surgery	Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood transfusion rate within 21 days after surgery	Day 21
Hb levels 14 days after surgery	Day 14

Collaborators and Investigators

• Sponsor: Tang Xiaodong

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 28, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: anemia; Blood management; perioperative; bone tumor
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia; Bone Neoplasms
• Other Study ID Numbers: PKUPH-anemia-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No