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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin level on postoperative day 5 | Haemoglobin level on postoperative day 5 | Haemoglobin level on postoperative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effect of combination therapy on changes in perioperative haemoglobin levels |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Yan | Contact | 13757118632 | zryanmin@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Min Yan, Doctor | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University Medical College | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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Double blinding is not feasible
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|
| 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 |
|
Pre-intervention versus post-operative haemoglobin |
| 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 | 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 | 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 | 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 | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first |
| Infusion reactions and allergies | Perioperative allergic events | 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 | Through study completion, an average of 1.5 year |
| All-cause mortality within 6 months of surgery | Incidence of mortality | Through study completion, an average of 1.5 year |
| Total length of hospital stay | Total length of hospital stay | Through study completion, an average of 1 year |
| Incidence of perioperative infections | Non-prophylactic use of antibiotics | Through study completion, an average of 1 year |
| Health Care Costs | All medical costs during hospitalisation | From admission until hospital discharge or postoperative day 30, whichever comes first |
| Post-operative hospital readmission rate | Post-operative hospital readmission rate | Through study completion, an average of 1 year |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |