Effect of the Combined Programme on Perioperative Anaemia（CPPA）

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353348
• Other study ID #: 2022-0156
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Yan
• Phone: 13757118632
• Email: zryanmin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Cardiac Surgery
• Iron Deficiency Anemia
• Patient Blood Management

Intervention

Drug:
• Iron Sucrose, recombinant human erythropoietin, ascorbic acid
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.
• saline
The standard treatment group will receive 200 ml of saline equal to the intervention group, and 1 ml of saline injected subcutaneously

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin level on postoperative day 5	Haemoglobin level on postoperative day 5	Haemoglobin level on postoperative day 5
Secondary	Amount of allogeneic blood products used in the perioperative period	(red blood cells, plasma, platelets)	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Secondary	Effect of combination therapy on changes in perioperative haemoglobin levels	Pre-intervention versus post-operative haemoglobin	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Secondary	Effect of combination therapy on changes in perioperative ferritin levels	Pre-intervention versus post-operative ferritin	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Secondary	Effect of combination therapy on changes in perioperative reticulocyte levels	Magnitude of reticulocyte elevation	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Secondary	Incidence of perioperative acute renal insufficiency	Postoperative creatinine more than 2 times higher than preoperative or oliguria (<0.5ml/kg/h) within 12 hours	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Secondary	Post-operative intensive care unit stay	Length of stay in ICU after surgery	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Secondary	Infusion reactions and allergies	Perioperative allergic events	From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Secondary	Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery	Myocardial infarction?Ischemic cerebral infarction?arrhythmia?Deep vein thrombosis of the lower extremity?Pulmonary embolism, etc	Through study completion, an average of 1.5 year
Secondary	All-cause mortality within 6 months of surgery	Incidence of mortality	Through study completion, an average of 1.5 year
Secondary	Total length of hospital stay	Total length of hospital stay	Through study completion, an average of 1 year
Secondary	Incidence of perioperative infections	Non-prophylactic use of antibiotics	Through study completion, an average of 1 year
Secondary	Health Care Costs	All medical costs during hospitalisation	From admission until hospital discharge or postoperative day 30, whichever comes first
Secondary	Post-operative hospital readmission rate	Post-operative hospital readmission rate	Through study completion, an average of 1 year