Clinical trial NCT05353348: Effect of the Combined Programme on Perioperative Anaemia（CPPA）
Official title: Effectiveness of Iron Sucrose Combined With rHuEPO and Ascorbic Acid in Improving Perioperative Anaemia in Patients Undergoing Major Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Blood Management
Cardiac Surgery
Iron Deficiency Anemia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Haemoglobin level on postoperative day 5
timeFrame: Haemoglobin level on postoperative day 5
Secondary outcomes:
measure: Amount of allogeneic blood products used in the perioperative period
timeFrame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
measure: Effect of combination therapy on changes in perioperative haemoglobin levels
timeFrame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
measure: Effect of combination therapy on changes in perioperative ferritin levels
timeFrame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
measure: Effect of combination therapy on changes in perioperative reticulocyte levels
timeFrame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
measure: Incidence of perioperative acute renal insufficiency
timeFrame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
measure: Post-operative intensive care unit stay
timeFrame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
measure: Infusion reactions and allergies
timeFrame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
measure: Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery
timeFrame: Through study completion, an average of 1.5 year
measure: All-cause mortality within 6 months of surgery
timeFrame: Through study completion, an average of 1.5 year
measure: Total length of hospital stay
timeFrame: Through study completion, an average of 1 year
measure: Incidence of perioperative infections
timeFrame: Through study completion, an average of 1 year
measure: Health Care Costs
timeFrame: From admission until hospital discharge or postoperative day 30, whichever comes first
measure: Post-operative hospital readmission rate
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Min Yan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: