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

ConditionAnemia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTang Xiaodong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Isomaltose Anhydride Iron GroupExperimental treatment 1 intervention
Group B: Conventional treatment groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hb levels 21 days after surgery

Time frame
Day 21

Secondary outcomes

1

Blood transfusion rate within 21 days after surgery

Time frame
Day 21
2

Hb levels 14 days after surgery

Time frame
Day 14

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang Xiaodong

Lead sponsor

Peking University People's Hospital

Sponsor institution

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