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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
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.
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
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
RECRUITINGHaemoglobin level on postoperative day 5
Haemoglobin level on postoperative day 5
Time frame: Haemoglobin level on postoperative day 5
Amount of allogeneic blood products used in the perioperative period
(red blood cells, plasma, platelets)
Time frame: 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
Pre-intervention versus post-operative haemoglobin
Time frame: 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
Pre-intervention versus post-operative ferritin
Time frame: 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
Magnitude of reticulocyte elevation
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Incidence of perioperative acute renal insufficiency
Postoperative creatinine more than 2 times higher than preoperative or oliguria (\<0.5ml/kg/h) within 12 hours
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Post-operative intensive care unit stay
Length of stay in ICU after surgery
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Infusion reactions and allergies
Perioperative allergic events
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
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
Time frame: Through study completion, an average of 1.5 year
All-cause mortality within 6 months of surgery
Incidence of mortality
Time frame: Through study completion, an average of 1.5 year
Total length of hospital stay
Total length of hospital stay
Time frame: Through study completion, an average of 1 year
Incidence of perioperative infections
Non-prophylactic use of antibiotics
Time frame: Through study completion, an average of 1 year
Health Care Costs
All medical costs during hospitalisation
Time frame: From admission until hospital discharge or postoperative day 30, whichever comes first
Post-operative hospital readmission rate
Post-operative hospital readmission rate
Time frame: Through study completion, an average of 1 year
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