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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
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.
Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGQuality of Life (EQ-5D)
Assessment of health-related quality of life using the EuroQol 5-Dimension (EQ-5D) questionnaire
Time frame: 1 year postoperatively (±30 days)
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Evaluation of sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 year postoperatively (±30 days)
Fatigue (FACIT-Fatigue Scale)
Measurement of fatigue level using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
Time frame: 1 year postoperatively (±30 days)
All-cause Complications
Occurrence of any postoperative complications from any cause during the 1-year follow-up period
Time frame: Up to 1 year postoperatively
Hospital Readmission
Any hospital readmission for any cause within 1 year after surgery.
Time frame: Up to 1 year postoperatively
Repeat Cardiac Surgery
Any subsequent cardiac surgery (reoperation) within 1 year after the index surgery.
Time frame: Up to 1 year postoperatively
All-cause Mortality
Death from any cause within 1 year after surgery.
Time frame: Up to 1 year postoperatively
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