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Heart surgery patients may avoid transfusions with new iron cocktail

NCT ID NCT06012760

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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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
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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a combination of iron, erythropoietin, and vitamin C before major heart surgery can lower the need for blood transfusions in adults with iron-deficiency anemia. About 400 participants will receive either the combined regimen or standard care. The goal is to see if this approach is safe and effective at reducing transfusions during and after surgery.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

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

Started

Jan 2025

Expected to finish

Mar 2028

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 years and older

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: 1. Participants must be at least 18 years of age. 2. Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both. 3. Iron deficiency anemia is defined as having a ferritin level below 100 μg/L or a ferritin level below 300 μg/L accompanied by a transferrin saturation below 25%. Additionally, hemoglobin levels should range between 90 and 130 g/L for men or between 90 and 120 g/L for women. 4. The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3. 5. Prior to participation, the patient or their legal representative must provide informed consent. Exclusion Criteria: 1. Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO. 2. Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics. 3. Individuals with a weight equal to or less than 50kg. 4. Individuals with a family history of haemochromatosis or thalassaemia, or those with a transferrin saturation level exceeding 50% or a documented history of iron overload. 5. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc. 6. Requirement for emergency surgical intervention. 7. Severe hepatic or renal impairment, ALT \>3 times the upper limit of normal value or AST \>3 times the upper limit of normal value, creatinine \>1.5 times the upper limit of normal value 8. Pregnant or lactating women 9. history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery 10. Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.

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Conditions

The condition(s) this trial relates to.

anemia iron deficiency anemia

As listed by the trial registrant

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

Anemia Cardiac surgery Iron deficiency anemia Perioperative Transfusion

How to take part

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  1. The places running it

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  2. The official record

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

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Second Affiliated Hospital of Zhejiang University anesthesiology department

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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