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NCT06012760 | RECRUITING | Anemia

The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Condition or disease

Anemia

Iron Deficiency Anemia

Perioperative

Transfusion

Cardiac Surgery

Intervention/treatment

Iron sucrose, Human Erythropoietin Injection, Vitamin C

Standard Medical Care

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Effect of Iron Sucrose Combined With Human Erythropoietin and Vitamin C on Perioperative Allogeneic Red Blood Cell Infusion in Major Cardiac Surgery
Actual Study Start Date : 2024-04-01
Estimated Primary Completion Date : 2026-01-31
Estimated Study Completion Date : 2026-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion

Location Details

NCT06012760

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Locations

RECRUITING

China, Zhejiang

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, China, 310000