Perioperative Blood Conservation: Role of Combined Iron Supplementation Protocols in Reducing Allogeneic Transfusion
- Conditions
- AnemiaIron DeficienciesCardiac Surgery
- Interventions
- Drug: Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin CProcedure: Routine perioperative management
- Registration Number
- NCT06968936
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
The goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. The main questions it aims to answer are:
Does the combined regimen lower the amount of allogeneic red blood cell transfusion needed during and after surgery?
Are there any side effects or safety concerns associated with the regimen?
Researchers will compare the combined iron supplementation (sucrose iron, erythropoietin, and vitamin C) to standard care to see if it helps reduce blood transfusions.
Participants will:
Receive either the combined regimen or standard care before surgery
Undergo major elective cardiac surgery under general anesthesia
Be monitored for blood transfusion needs and recovery up to 90 days after surgery
- Detailed Description
1. Hypothesis:The combined protocol of preoperative sucrose iron, human erythropoietin, and vitamin C will demonstrate superiority in reducing perioperative allogeneic red blood cell (RBC) transfusion volume compared to standard care in patients with iron deficiency anemia undergoing major cardiac surgery with cardiopulmonary bypass.
2. Interventions 2.1.Experimental group: Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU/kg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds.
2.2.Control group: Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.
3. Primary endpoint: Total volume of allogeneic RBC transfusion (units) from surgery initiation to postoperative day 5.
4. Stratification in randomization: Stratification factors include types of surgery, preoperative baseline hemoglobin level.
5. Outcome assessors will be blinded to group allocation to reduce assessment bias.
6. Follow-up time points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery.
7. When the patient's hemoglobin concentration falls below the threshold of 70 g/L during surgery or ICU monitoring, or below 70-80 g/L in the general ward, and/or when signs of anemia or hemodynamic instability are present-including shock, severe arrhythmias, respiratory distress, heart rate \>120 beats/min, systolic blood pressure (SBP) \<80 mmHg, mean arterial pressure (MAP) \<55-60 mmHg, or a reduction in SBP or MAP exceeding 25% from baseline-these findings may indicate significant hypovolemia and warrant consideration of transfusion intervention.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Participants must be at least 18 years of age.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined Iron Supplementation Group Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU/kg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds Conventional treatment group Routine perioperative management Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices
- Primary Outcome Measures
Name Time Method The volume of allogeneic red blood cell transfusions during the perioperative period. From the initiation of the surgical procedure until five days post-surgery. The volume of allogeneic red blood cell transfusions during the perioperative period.
- Secondary Outcome Measures
Name Time Method Infections From the initiation of the surgical procedure until discharge. Perioperative Pneumonia, hospital acquired Deep Sternal Wound Infection
Definition of infection: rise in inflammation markers after the initial postoperative period (acute phase reaction) and requires treatment and/ or prolongs days in hospital and/or microbiological confirmation of infectionThrombotic and thromboembolic complications From the initiation of the surgical procedure until discharge. Perioperative clinical symptoms and evidence of thrombosis/ embolism in one of the following imaging methods (ultrasound, CT-scan)
30 day and 90-day mortality From the initiation of the surgical procedure until discharge. Perioperative mortality
Costs (for blood products and pharmaceutical products related to transfusion and anemia management) From the initiation of the surgical procedure until discharge. Perioperative Comparison of costs for study medication versus costs for blood products and products related to transfusion
All serious adverse events From the initiation of the surgical procedure until discharge. Perioperative Comparison of all serious adverse events between study intervention group and control group
Length of stay (LOS) in the hospital Within 90± 7 days after surgery The time elapsed between a patient's hospital admittance and discharge
New atrial fibrillation From the point of randomisation until 90± 7 days following the surgical procedure. New atrial fibrillation (AF) is defined as a new onset or a first detectable episode of AF, whether symptomatic or not
Percentage of patients with any RBC transfusions From the initiation of the surgical procedure until discharge. Perioperative The percentage of allogeneic red blood cell transfusions during the perioperative period.
Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets) From the initiation of the surgical procedure until discharge. Perioperative volume and Percentage
Perioperative Hb concentrations Follow-up time points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery. hemoglobin
The alterations in ferritin levels and TSAT during the perioperative period. 6.Follow-up time points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery. ferritin、Transferrin Saturation
The alterations in reticulocyte levels during the perioperative period. 6.Follow-up time points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery. reticulocyte
The score measuring the quality of life after surgery. From the point of randomisation until 90± 7 days following the surgical procedure. 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.
Acute kidney failure From the initiation of the surgical procedure until 7 days post-surgery. Acute kidney injury used to be called acute kidney failure. Acute kidney injury is most common in people who are in the hospital, mostly in people who need intensive care.
Major Adverse Cardiac and Cerebrovascular Events (MACCE) From the point of randomisation until 90± 7 days following the surgical procedure. Myocardial infarction, stroke, death
Length of stay in the intensive care unit (ICU) Within 90± 7 days after surgery
Trial Locations
- Locations (1)
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine🇨🇳Hangzhou, Zhejiang, ChinaMin YanContact+861375711863zryanmin@zju.edu.cn