Perioperative Blood Conservation: Role of Combined Iron Supplementation Protocols in Reducing Allogeneic Transfusion

Phase

N/A

Condition

Anemia

Cardiac Surgery

Treatment

Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C

Routine perioperative management

Clinical Study ID

NCT06968936

20240384

Ages 18-85
All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants must be at least 18 years of age.
Major cardiac surgery should encompass procedures such as coronary artery bypassgrafting (CABG), valve surgery, or a combination of both.
Iron deficiency anemia is defined as having a ferritin level below 100 μg/L or aferritin 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 orbetween 90 and 120 g/L for women.
The American Society of Anesthesiologists (ASA) classification should fall withinGrade 1-3.
Prior to participation, the patient or their legal representative must provideinformed consent.

Exclusion

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-prophylacticantibiotics.
Individuals with a weight equal to or less than 50kg.
Individuals with a family history of haemochromatosis or thalassaemia, or those witha transferrin saturation level exceeding 50% or a documented history of ironoverload.
Presence of other known haematological disorders such as folic acid or vitamin B12deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PDdeficiency, etc.
Requirement for emergency surgical intervention.
Severe hepatic or renal impairment, ALT >3 times the upper limit of normal value orAST >3 times the upper limit of normal value, creatinine >1.5 times the upper limitof normal value
Pregnant or lactating women
history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeksprior to surgery
Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.

Study Design

Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C

May 15, 2025

September 30, 2027

Study Description

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.
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.
Primary endpoint: Total volume of allogeneic RBC transfusion (units) from surgery initiation to postoperative day 5.
Stratification in randomization: Stratification factors include types of surgery, preoperative baseline hemoglobin level.
Outcome assessors will be blinded to group allocation to reduce assessment bias.
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.
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.

Connect with a study center

Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 330100
China
Active - Recruiting

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