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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05353348
Other study ID # 2022-0156
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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