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NCT Number: NCT05353348

Effect of the Combined Programme on Perioperative Anaemia（CPPA）

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.

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Key information

Conditions

Patient Blood Management Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Cardiac Surgery Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Min Yan, Doctor

CONTACT

[email protected]

15888210247

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron Sucrose, recombinant human erythropoietin, ascorbic acid

Drug

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.

Conventional treatment

Procedure

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 outcomes

  1. Haemoglobin level on postoperative day 5

    Time frame: Haemoglobin level on postoperative day 5

    Haemoglobin level on postoperative day 5

Secondary outcomes

  1. 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

    (red blood cells, plasma, platelets)

  2. 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

    Pre-intervention versus post-operative haemoglobin

  3. 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

    Pre-intervention versus post-operative ferritin

  4. 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

    Magnitude of reticulocyte elevation

  5. Incidence of perioperative acute renal insufficiency

    Time frame: 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

  6. Post-operative intensive care unit stay

    Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first

    Length of stay in ICU after surgery

  7. Infusion reactions and allergies

    Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first

    Perioperative allergic events

  8. 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

    Myocardial infarction、Ischemic cerebral infarction、arrhythmia、Deep vein thrombosis of the lower extremity、Pulmonary embolism, etc

  9. All-cause mortality within 6 months of surgery

    Time frame: Through study completion, an average of 1.5 year

    Incidence of mortality

  10. Total length of hospital stay

    Time frame: Through study completion, an average of 1 year

    Total length of hospital stay

  11. Incidence of perioperative infections

    Time frame: Through study completion, an average of 1 year

    Non-prophylactic use of antibiotics

  12. Health Care Costs

    Time frame: From admission until hospital discharge or postoperative day 30, whichever comes first

    All medical costs during hospitalisation

  13. Post-operative hospital readmission rate

    Time frame: Through study completion, an average of 1 year

    Post-operative hospital readmission rate

Study contacts

Contact information is provided by the study sponsor or research team.

Min Yan

CONTACT

[email protected]

13757118632

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2022
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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