ClinicalTrials.gg
Not yet recruitingNCT07314424Updated Jan 2, 2026

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

A Phase 4 interventional study of isomaltose iron in Anemia, sponsored by Tang Xiaodong. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Tang Xiaodong · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Anemia

Keywords

  • anemia
  • bone tumor
  • perioperative
  • Blood management
03

In context

Anemia

1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.

This study's planned enrollment of 160 is above the median of 117 across 1,336 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Tang Xiaodong is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 and above with primary malignant bone tumors and bone who plan to undergo open surgery for the sacrum, pelvis, and spine.
  • 5 ± 2 days before surgery, \<130g/L, or iron deficiency (TSAT\<20%)
  • Patients are able to understand the research content and sign forms

Exclusion criteria

Exclusion criteria:

Meet any of the following criteria;

  • Ferritin>800 ng/ml or \<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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • 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

  • No intervention
    Conventional treatment group

    Traditional symptomatic treatment

Interventions

  • Drugisomaltose 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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07314424
Lead sponsor
Tang Xiaodong
Responsible party
Tang Xiaodong (professor, Peking University People's Hospital) — Sponsor-investigator
First posted
Jan 2, 2026
Start date
Jan 1, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Jan 2, 2026

Study contacts

Tang Xiaodong
Contact
tang15877@126.com
010-88326196

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion