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The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion (CIPAT)

Zhejiang University logo

Zhejiang University

Status

Enrolling

Conditions

Iron Deficiency Anemia
Anemia
Cardiac Surgery
Perioperative
Transfusion

Treatments

Drug: Standard Medical Care
Drug: Iron sucrose, Human Erythropoietin Injection, Vitamin C

Study type

Interventional

Funder types

Other

Identifiers

NCT06012760
A2023519

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 2 patient groups

Combined Iron Protocols group(CIP group)
Experimental group
Description:
Preoperative randomization was conducted, followed by a three-day regimen in the week preceding surgery, involving the administration of intravenous iron sucrose at a dosage of 200 mg per day, vitamin C at a dosage of 2 g per day, and subcutaneous administration of Human Erythropoietin Injection at a dosage of 150 IU per kilogram.
Treatment:
Drug: Iron sucrose, Human Erythropoietin Injection, Vitamin C
Standard Medical Care group(SMC group)
Active Comparator group
Description:
Standard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
Treatment:
Drug: Standard Medical Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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