AnemiaPhase 4NCT07314424
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 study testing isomaltose iron in people with Anemia, run by Tang Xiaodong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anemia
- What is being tested?
- isomaltose iron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Conditions
- Anemia
- Being tested
- isomaltose iron
- Keywords
- anemia, bone tumor, perioperative, Blood management
- Medical subject headings
- Anemia, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isomaltose ironDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Isomaltose Anhydride Iron Group | Experimental | 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 Receives: Drug: isomaltose iron |
| Conventional treatment group | No intervention | Traditional symptomatic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb levels 21 days after surgery
Measured: Day 21
Secondary outcomes (2)
Blood transfusion rate within 21 days after surgery
Measured: Day 21
Hb levels 14 days after surgery
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang Xiaodong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tang Xiaodong, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314424
- Sponsor's protocol ID
- PKUPH-anemia-001
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07314424
- Acronym / sponsor ID
- PKUPH-anemia-001
- Conditions
- Anemia
- Keywords
- anemia, bone tumor, perioperative, Blood management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tang XiaodongUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isomaltose Anhydride Iron Group | Experimental | Drug: isomaltose ironCalculate 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 |
| Conventional treatment group | No intervention | –Traditional symptomatic treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isomaltose ironCalculate 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 Anhydride Iron Group |
Primary outcome
Hb levels 21 days after surgery
Time frame: Day 21
2 secondary outcomes
Blood transfusion rate within 21 days after surgery
Time frame: Day 21
Hb levels 14 days after surgery
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing isomaltose iron in people with Anemia, run by Tang Xiaodong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tang Xiaodong (010-88326196, tang15877@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hb levels 21 days after surgery (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.