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Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Qi Gao, Dr.
gaoqi19950203@163.com
19857136919
Time Frame
Start Date: 2026-03-27
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 400
Treatments
Experimental: Combined Iron Supplementation Group
Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU/kg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds
Active_comparator: Conventional treatment group
Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Zhejiang Provincial People's Hospital

This content was sourced from clinicaltrials.gov