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

Primary Purpose

Anemia, Iron Deficiency Anemia, Perioperative

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Iron sucrose, Human Erythropoietin Injection, Vitamin C
Saline
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital of Zhejiang University anesthesiology departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm 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.

Preoperative randomization was conducted, followed by the administration of 200 ml of saline via intravenous infusion and 1 ml of saline via subcutaneous injection for three consecutive days in the week preceding the surgery.

Outcomes

Primary Outcome Measures

Perioperative allogeneic red blood cell transfusion volume
The volume of allogeneic red blood cell transfusions during the perioperative period.

Secondary Outcome Measures

The quantity and percentage of allogeneic blood products utilized during the perioperative period.
This encompasses blood components such as plasma and platelets, erythrocytes.
The alterations in perioperative haemoglobin levels.
Haemoglobin levels were assessed at various time intervals.
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.
The alterations in reticulocyte levels during the perioperative period.
Reticulocyte levels were measured at various time intervals.
NYHA classification of cardiac function
NYHA classification of cardiac function values were assessed at various time intervals.
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.
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.
The mortality rate within a 90-day postoperative period.
The mortality rate within a 90-day postoperative period.
length of stay in hospital
he time period from admission to the hospital to discharge
Length of stay in ICU
The time period from admission to ICU after surgery to move out from ICU to normal ward

Full Information

First Posted
August 22, 2023
Last Updated
August 22, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT06012760
Brief Title
The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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. The sample size calculation for this study involved a randomised controlled trial with a parallel design. The intervention group consisted of individuals receiving combination therapy, while the control group received a placebo. The primary outcome indicator observed in the study population was perioperative blood transfusion. Our centre's pre-trial data survey indicated a perioperative blood transfusion rate of 1.8 U in the control group. It was hypothesized that the combination therapy would result in a reduction of blood transfusion by at least 0.5 U.The blood transfusion in the combination therapy group was 1.3. Setting α=0.05 (bilaterally) with a degree of certainty=0.90. Using the bilaterally Mann-Whitney U or the Wilcoxon Rank-Sum test at the 0.05 level of significance (α ), when the mean difference of the null hypothesis was 0. Based on Poisson distribution, the sample size N1 = 188 for the combination treatment group and N2 = 188 cases for the placebo control group was calculated using PASS 21 software. Assuming a 20% loss-to-follow-up rate of study participants, a sample size of at least N1 = 188 ÷ 0.8 = 235 cases and N2 = 188 ÷ 0.8 = 235 cases would be required. In the end, 240 study subjects were included in the combination treatment group and 240 in the placebo control group, for a total of 480 cases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency Anemia, Perioperative, Transfusion, Cardiac Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Preoperative randomization was conducted, followed by the administration of 200 ml of saline via intravenous infusion and 1 ml of saline via subcutaneous injection for three consecutive days in the week preceding the surgery.
Intervention Type
Drug
Intervention Name(s)
Iron sucrose, Human Erythropoietin Injection, Vitamin C
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
The participants were administered a placebo regimen consisting of saline three times in the week preceding the surgical procedure.
Primary Outcome Measure Information:
Title
Perioperative allogeneic red blood cell transfusion volume
Description
The volume of allogeneic red blood cell transfusions during the perioperative period.
Time Frame
From the initiation of the surgical procedure until five days post-surgery.
Secondary Outcome Measure Information:
Title
The quantity and percentage of allogeneic blood products utilized during the perioperative period.
Description
This encompasses blood components such as plasma and platelets, erythrocytes.
Time Frame
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.
Title
The alterations in perioperative haemoglobin levels.
Description
Haemoglobin levels were assessed at various time intervals.
Time Frame
From the point of randomisation until 90± 7 days following the surgical procedure.
Title
The alterations in ferritin levels and serum total iron binding capacity during the perioperative period.
Description
Ferritin and serum total iron binding capacity values were assessed at various time intervals.
Time Frame
From the point of randomisation until 90± 7 days following the surgical procedure.
Title
The alterations in reticulocyte levels during the perioperative period.
Description
Reticulocyte levels were measured at various time intervals.
Time Frame
From the point of randomisation until 90± 7 days following the surgical procedure.
Title
NYHA classification of cardiac function
Description
NYHA classification of cardiac function values were assessed at various time intervals.
Time Frame
From the point of randomisation until 90± 7 days following the surgical procedure.
Title
The score measuring the quality of life after surgery.
Description
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.
Time Frame
The time intervals of 30±7 days and 90±7 days were observed following the surgical procedure.
Title
Incidence of perioperative complication within 90 days after major cardiac surgery
Description
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.
Time Frame
Within 90 days after surgery
Title
The mortality rate within a 90-day postoperative period.
Description
The mortality rate within a 90-day postoperative period.
Time Frame
Within 90 days after surgery
Title
length of stay in hospital
Description
he time period from admission to the hospital to discharge
Time Frame
through study completion, an average of 14 days
Title
Length of stay in ICU
Description
The time period from admission to ICU after surgery to move out from ICU to normal ward
Time Frame
through study completion, an average of 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be at least 18 years of age. The initial elective major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both. 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. The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3. Prior to participation, the patient or their legal representative must provide informed consent. Exclusion Criteria: Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO. Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics. Individuals with a weight equal to or less than 50kg. 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. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc. Requirement for emergency surgical intervention. 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 Pregnant or lactating women history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University anesthesiology department
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
Phone
15888210247
Email
zryanmin@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Other researchers could email us to ask the data information.

Learn more about this trial

The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion

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