Effect of the Combined Programme on Perioperative Anaemia（CPPA）

Zhejiang University

Status: Enrolling

Conditions: Iron Deficiency Anemia; Patient Blood Management; Cardiac Surgery

Treatments: Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acid; Procedure: conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05353348

2022-0156

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid
2. Patients with a preoperative temperature >37.5 °C or on non-prophylactic antibiotics
3. Pregnancy or breastfeeding stage
4. weight ≤ 50 kg
5. Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout
6. Chronic liver disease and/or screening alanine transferase/aspartate transferase above normal 3 times or more above the upper limit of the normal range
7. Family history of haemochromatosis, thalassaemia or transferrin saturation > 50%
8. Known history of iron overload
9. Other known causes of anaemia (folic acid or vitamin B12 deficiency or haemoglobinopathies, etc.)
10. Emergency surgery
11. Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior to surgery

Withdrawal criteria:

1. massive blood transfusion (≥ 10 red blood cells (RBC)/24h)
2. Preoperative interventions not performed according to standard
3. Cancellation of surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Iron treatment intervention arm

Experimental group

Description:

The combination therapy group will receive three treatments consisting of 200 mg/100 ml of iron sucrose IV infusion, 150 IU/Kg of erythropoietin subcutaneously and 2 mg/100 ml of vitamin C IV infusion in the week prior to surgery

Treatment:

Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acid

conventional treatment arm

Active Comparator group

Description:

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

Treatment:

Procedure: conventional treatment