NCT06968936 Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy
| NCT ID | NCT06968936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-03-27 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2026-03-27 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06968936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06968936 currently recruiting?
Yes, NCT06968936 is actively recruiting participants. Contact the research team at gaoqi19950203@163.com for enrollment information.
Where is the NCT06968936 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06968936 clinical trial?
NCT06968936 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 400 participants.