The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion (NCT06012760) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
China400 participantsStarted 2025-01-04
Plain-language summary
The goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. The main questions it aims to answer are:
Does the combined regimen lower the amount of allogeneic red blood cell transfusion needed during and after surgery?
Are there any side effects or safety concerns associated with the regimen?
Researchers will compare the combined iron supplementation (sucrose iron, erythropoietin, and vitamin C) to standard care to see if it helps reduce blood transfusions.
Participants will:
Receive either the combined regimen or standard care before surgery
Undergo major elective cardiac surgery under general anesthesia
Be monitored for blood transfusion needs and recovery up to 90 days after surgery
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must be at least 18 years of age.
. Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.
. 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.
. The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.
. Prior to participation, the patient or their legal representative must provide informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perioperative allogeneic red blood cell transfusion volume
Timeframe: From the initiation of the surgical procedure until five days post-surgery.
Trial details
NCT IDNCT06012760
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.
. Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.
. Individuals with a weight equal to or less than 50kg.
. 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.
. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.
. Requirement for emergency surgical intervention.
. 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