Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 330100, China
Location status: Recruiting
NCT Number: NCT06968936
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 330100, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Routine perioperative management
Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.
Time frame: 1 year postoperatively (±30 days)
Assessment of health-related quality of life using the EuroQol 5-Dimension (EQ-5D) questionnaire
Time frame: 1 year postoperatively (±30 days)
Evaluation of sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 year postoperatively (±30 days)
Measurement of fatigue level using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
Time frame: Up to 1 year postoperatively
Occurrence of any postoperative complications from any cause during the 1-year follow-up period
Time frame: Up to 1 year postoperatively
Any hospital readmission for any cause within 1 year after surgery.
Time frame: Up to 1 year postoperatively
Any subsequent cardiac surgery (reoperation) within 1 year after the index surgery.
Time frame: Up to 1 year postoperatively
Death from any cause within 1 year after surgery.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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