The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Aug 22, 2023

Keywords

ClinConnect Summary

The CIPAT study is a clinical trial aimed at understanding whether a special combination of iron supplements can help patients with iron deficiency anemia who are undergoing major heart surgery. Researchers believe that giving these patients iron, along with a hormone that helps produce red blood cells and vitamin C, before their surgery might reduce the need for blood transfusions. Participants in the trial will be randomly placed into two groups: one will receive the iron combination, while the other will receive a placebo (a treatment that looks the same but has no active ingredients). The main goal is to see if those receiving the iron supplements need fewer blood transfusions during and after their surgery.

To join this study, participants must be at least 18 years old and scheduled for specific heart surgeries, such as bypass surgery or valve repairs. They should have iron deficiency anemia, which means their iron levels are low, and they should not have certain health conditions that could complicate the use of iron supplements. All participants will be informed about the study and must agree to take part. It’s important to know that this trial is currently recruiting participants, and it aims to help improve care for those with anemia undergoing cardiac surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must be at least 18 years of age.
• • 2. Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.
• • 3. 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.
• • 4. The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.
• • 5. Prior to participation, the patient or their legal representative must provide informed consent.
• Exclusion Criteria:
• • 1. Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.
• • 2. Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.
• • 3. Individuals with a weight equal to or less than 50kg.
• • 4. 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.
• • 5. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.
• • 6. Requirement for emergency surgical intervention.
• • 7. Severe hepatic or renal impairment, ALT \>3 times the upper limit of normal value or AST \>3 times the upper limit of normal value, creatinine \>1.5 times the upper limit of normal value
• • 8. Pregnant or lactating women
• • 9. history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery
• • 10. Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.