Effect of the Combined Programme on Perioperative Anaemia（CPPA）

Official title

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

Overview

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.

Interventions

• Drug Iron 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.
• Procedure conventional 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

Primary outcome measures

• Haemoglobin level on postoperative day 5 [Time frame: Haemoglobin level on postoperative day 5]

Secondary outcome measures (12)

• Amount of allogeneic blood products used in the perioperative period [Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
• Effect of combination therapy on changes in perioperative haemoglobin levels [Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
• Effect of combination therapy on changes in perioperative ferritin levels [Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
• Effect of combination therapy on changes in perioperative reticulocyte levels [Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
• Incidence of perioperative acute renal insufficiency [Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
• Post-operative intensive care unit stay [Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
• Infusion reactions and allergies [Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
• Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery [Time frame: Through study completion, an average of 1.5 year]
• All-cause mortality within 6 months of surgery [Time frame: Through study completion, an average of 1.5 year]
• Total length of hospital stay [Time frame: Through study completion, an average of 1 year]
• Incidence of perioperative infections [Time frame: Through study completion, an average of 1 year]
• Health Care Costs [Time frame: From admission until hospital discharge or postoperative day 30, whichever comes first]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Affiliated Hospital of Zhejiang University Medical College — Hangzhou

Identifiers

NCT: NCT05353348 · 2022-0156

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗