The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion

Anemia Clinical Trial

— CIPAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012760
• Other study ID #: A2023519
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: August 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Iron sucrose, Human Erythropoietin Injection, Vitamin C
The participants were administered a combined iron supplementation regimen consisting of iron sucrose,Human Erythropoietin Injection, and vitamin C, three times throughout the preoperative week.
• Standard Medical Care
Standard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative allogeneic red blood cell transfusion volume	The volume of allogeneic red blood cell transfusions during the perioperative period.	From the initiation of the surgical procedure until five days post-surgery.
Secondary	The quantity and percentage of allogeneic blood products utilized during the perioperative period.	This encompasses blood components such as plasma and platelets, erythrocytes.	From the initiation of the surgical procedure until the patient's release from the hospital or the 30th day following the operation, whichever occurs earlier.
Secondary	The alterations in perioperative haemoglobin levels.	Haemoglobin levels were assessed at various time intervals.	From the point of randomisation until 90± 7 days following the surgical procedure.
Secondary	The alterations in ferritin levels and serum total iron binding capacity during the perioperative period.	Ferritin and serum total iron binding capacity values were assessed at various time intervals.	From the point of randomisation until 90± 7 days following the surgical procedure.
Secondary	The alterations in reticulocyte levels during the perioperative period.	Reticulocyte levels were measured at various time intervals.	From the point of randomisation until 90± 7 days following the surgical procedure.
Secondary	NYHA classification of cardiac function	NYHA classification of cardiac function values were assessed at various time intervals.	From the point of randomisation until 90± 7 days following the surgical procedure.
Secondary	The score measuring the quality of life after surgery.	The findings are presented based on the EQ VAS score (0-100), which reflects the overall self-assessed health status. A higher score indicates a better health status. Additionally, the results are reported using the EQ-5D-3L Effectiveness Index (EQ-5D-3L) values (5-15), where a lower EQ-5D-3L value signifies a better state of health.	The time intervals of 30±7 days and 90±7 days were observed following the surgical procedure.
Secondary	Incidence of perioperative complication within 90 days after major cardiac surgery	The potential postoperative complications within a 90-day timeframe encompass myocardial injury after noncardiac surgery (MINS), acute kidney injury (AKI), serious adverse events (SAE), congestive heart failure, respiratory failure, and various infections.	Within 90 days after surgery
Secondary	The mortality rate within a 90-day postoperative period.	The mortality rate within a 90-day postoperative period.	Within 90 days after surgery
Secondary	length of stay in hospital	he time period from admission to the hospital to discharge	through study completion, an average of 14 days
Secondary	Length of stay in ICU	The time period from admission to ICU after surgery to move out from ICU to normal ward	through study completion, an average of 4 days