Effect of the Combined Programme on Perioperative Anaemia（CPPA）

Not Applicable

Recruiting

• Conditions: Cardiac Surgery; Patient Blood Management; Iron Deficiency Anemia
• Interventions: Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acid; Procedure: conventional treatment

• Registration Number: NCT05353348
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Study Start: 2023-03-15
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron treatment intervention arm	Iron Sucrose, recombinant human erythropoietin, ascorbic acid	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
conventional treatment arm	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

Name	Time	Method
Haemoglobin level on postoperative day 5	Haemoglobin level on postoperative day 5	Haemoglobin level on postoperative day 5

Secondary Outcome Measures

Name	Time	Method
Post-operative intensive care unit stay	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first	Length of stay in ICU after surgery
Health Care Costs	From admission until hospital discharge or postoperative day 30, whichever comes first	All medical costs during hospitalisation
Effect of combination therapy on changes in perioperative haemoglobin levels	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first	Pre-intervention versus post-operative haemoglobin
Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery	Through study completion, an average of 1.5 year	Myocardial infarction、Ischemic cerebral infarction、arrhythmia、Deep vein thrombosis of the lower extremity、Pulmonary embolism, etc
Total length of hospital stay	Through study completion, an average of 1 year	Total length of hospital stay
Effect of combination therapy on changes in perioperative ferritin levels	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first	Pre-intervention versus post-operative ferritin
Incidence of perioperative acute renal insufficiency	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first	Postoperative creatinine more than 2 times higher than preoperative or oliguria (\<0.5ml/kg/h) within 12 hours
Post-operative hospital readmission rate	Through study completion, an average of 1 year	Post-operative hospital readmission rate
Amount of allogeneic blood products used in the perioperative period	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first	(red blood cells, plasma, platelets)
Infusion reactions and allergies	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first	Perioperative allergic events
Effect of combination therapy on changes in perioperative reticulocyte levels	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first	Magnitude of reticulocyte elevation
All-cause mortality within 6 months of surgery	Through study completion, an average of 1.5 year	Incidence of mortality
Incidence of perioperative infections	Through study completion, an average of 1 year	Non-prophylactic use of antibiotics

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University Medical College; 🇨🇳 Hangzhou, Zhejiang, China