Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C
- Routine perioperative management
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Zhejiang Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov