Effect of the Combined Programme on Perioperative Anaemia（CPPA）

NCT05353348 | Recruiting

• 1 other identifier: 2022-0156
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Blood Management; Cardiac Surgery; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Haemoglobin level on postoperative day 5

  Haemoglobin level on postoperative day 5

  Haemoglobin level on postoperative day 5

Secondary Outcomes (13)

• 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

• 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

• 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

• 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

• Incidence of perioperative acute renal insufficiency

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

Study Arms (2)

Iron treatment intervention arm

EXPERIMENTAL

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

Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acid

conventional treatment arm

ACTIVE COMPARATOR

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

Procedure: conventional treatment

Interventions

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.

Iron treatment intervention arm

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

conventional treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferric Oxide, Saccharated; Ascorbic Acid

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Min Yan, Doctor

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Yan

CONTACT

13757118632; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Double blinding is not feasible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 29, 2022
• Study Start: March 15, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2024-12

Locations

CN (1)