RecruitingNot ApplicableNCT05353348

Effect of the Combined Programme on Perioperative Anaemia（CPPA）

Effectiveness of Iron Sucrose Combined With rHuEPO and Ascorbic Acid in Improving Perioperative Anaemia in Patients Undergoing Major Cardiac Surgery

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

110 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Cardiac Surgery Patient Blood Management

Summary

We used the preoperative intervention of iron sucrose in combination with human erythropoietin and vitamin C as an innovative combination therapy. This combined treatment strategy aims to improve perioperative anaemia in patients by promoting erythropoiesis and improving iron metabolism. Compared with previous perioperative intravenous iron supplementation, this innovative combination therapy strategy takes into account multiple aspects of iron metabolism as well as the biological mechanisms of erythropoiesis, providing a more comprehensive intervention. Management of perioperative anaemia in previous studies has largely relied on single intravenous iron supplementation therapy, and although this approach has been effective in raising iron levels, its effectiveness may be limited in patients who have impaired iron utilisation or in situations where concurrent stimulation of erythropoiesis is required. The use of iron sucrose in combination with human erythropoietin and vitamin C, on the other hand, is based on an integrative therapeutic concept aimed at providing a more comprehensive response to perioperative anaemia by simultaneously promoting effective iron utilisation and erythropoiesis.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Age 18 years and above
Ferritin <300µg/L, transferrin saturation <25%, male 90<Hb<130g/L or female 90<Hb<120g/L
Elective major cardiac surgery (valve replacement, CABG coronary artery bypass surgery or a combination of both)
ASA: Grade 1-3
Signed informed consent

Exclusion Criteria15

Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid
Patients with a preoperative temperature >37.5 °C or on non-prophylactic antibiotics
Pregnancy or breastfeeding stage
weight ≤ 50 kg
Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout
Chronic liver disease and/or screening alanine transferase/aspartate transferase above normal 3 times or more above the upper limit of the normal range
Family history of haemochromatosis, thalassaemia or transferrin saturation > 50%
Known history of iron overload
Other known causes of anaemia (folic acid or vitamin B12 deficiency or haemoglobinopathies, etc.)
Emergency surgery
Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior to surgery
Withdrawal criteria:
massive blood transfusion (≥ 10 red blood cells (RBC)/24h)
Preoperative interventions not performed according to standard
Cancellation of surgery

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Interventions

DRUGIron Sucrose, recombinant human erythropoietin, ascorbic acid

During the 1 week period following admission, 3 consecutive dosing regimens were administered, 200 mg of iron sucrose by intravenous infusion at 8am daily in combination with 150 IU/kg of recombinant human erythropoietin by subcutaneous injection and 2 g of ascorbic acid by intravenous infusion.

PROCEDUREconventional treatment

Treatment in accordance with measures routinely used by the surgeon's team to treat anemia including but not limited to (clinical observation, oral iron supplementation, intravenous iron supplementation, blood transfusion, or other measures) will be documented faithfully by the study team