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New combo therapy aims to cut blood transfusions in bone tumor surgery

NCT ID NCT07314424

Disease control Sponsor: Tang Xiaodong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving a combination of intravenous iron, erythropoietin (EPO), and tranexamic acid before bone tumor surgery can improve hemoglobin levels and reduce the need for blood transfusions compared to usual care. The trial enrolls 160 adults with anemia or iron deficiency who are scheduled for open surgery on the pelvis, spine, or sacrum. The main goal is to measure hemoglobin levels 21 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intravenous ferric derisomaltose (iron), erythropoietin (EPO), and tranexamic acid
What this could lead to
If it works, this could establish a standard blood-management approach for bone tumor patients, reducing the need for blood transfusions and improving recovery.
What could go wrong
This is a single-center, early-phase trial with only 160 participants, so results may not apply broadly. The combination therapy also carries risks like allergic reactions or blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anemia bone cancer metastatic carcinoma in the bone

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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