Status:
RECRUITING
Effect of the Combined Programme on Perioperative Anaemia（CPPA）
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Patient Blood Management
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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 peri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05353348
Start Date
March 15 2023
End Date
April 1 2025
Last Update
January 10 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China, 310000