The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion — CIPAT  

Anemia Clinical Trial

Official title: Effect of Iron Sucrose Combined With Human Erythropoietin and Vitamin C on Perioperative Allogeneic Red Blood Cell Infusion in Major Cardiac Surgery

Status Recruiting

Clinical Trial Summary

Previous studies have shown that perioperative intravenous iron has a beneficial effect on patients with perioperative anaemia. To assess whether a combined iron supplementation regimen can reduce perioperative allogeneic blood transfusions in patients with iron deficiency anaemia undergoing major cardiac surgery under haemodynamic anaesthesia, a multicentre randomised clinical trial (CIPAT study) will be conducted. In the CIPAT study, patients undergoing elective major cardiac surgery under general anaesthesia will be randomly allocated to a control group and a combined iron supplementation group. Patients in the combined iron supplementation group will receive a combination iron supplementation regimen of iron sucrose in combination with Human Erythropoietin and vitamin C three times in the week prior to surgery, while patients in the control group will receive the same dose of placebo three times in the week prior to surgery. The primary endpoint is the volume of allogeneic erythrocyte infusion from the start of surgery to 5 days postoperatively. It is hypothesised that patients in the combined iron supplementation group will have fewer perioperative allogeneic red blood cell transfusions than those in the control group.

Clinical Trial Description

The objective of this study is to examine the potential of iron sucrose in conjunction with human erythropoietin and vitamin C to mitigate the need for perioperative allo-erythrocyte infusion in patients undergoing their initial elective major cardiac surgery. This will be achieved by assessing outcome measures including the quantity of perioperative allo-erythrocyte transfusion and the alteration in perioperative haemoglobin levels. ;

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Cardiac Surgery
• Iron Deficiency Anemia
• Perioperative
• Transfusion

• NCT number: NCT06012760
• Study type: Interventional
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Completion date: March 31, 2026