Effect of Perioperative Iron Treatment on Allogenic Blood Transfusion
Study Details
Study Description
Brief Summary
Perioperative anaemia is one of the most common comorbidities in patients undergoing surgery, with an incidence of 30.4% in patients undergoing non-cardiac surgery. Correcting perioperative anaemia and reducing complications are of great importance in improving the immediate and long-term prognosis of surgical patients. Therefore, this study investigates the effect of iron sucrose combined with rHuEPO on perioperative allogeneic red blood cell infusion in patients undergoing major non-cardiac surgery with cardiovascular risk.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Perioperative anaemia is one of the most common comorbidities in patients undergoing surgery, with an incidence of 30.4% in patients undergoing non-cardiac surgery. It can lead to ischaemia and hypoxia in vital organs, increased transfusion of allogeneic blood products, increased postoperative complications, increased mortality, and significantly longer ICU and hospital stays. Correcting perioperative anaemia and reducing complications are of great importance in improving the immediate and long-term prognosis of surgical patients. Both anaemia and iron deficiency are independent risk factors for poor prognosis in cardiovascular patients and are independent predictors of adverse cardiovascular events in the perioperative period. Moreover, in patients undergoing major non-cardiac surgery, the incidence of cardiovascular risk factors increased from 40.5% to 48.2% over 5 years. Therefore, this study investigates the effect of iron sucrose combined with rHuEPO on perioperative allogeneic red blood cell infusion in patients undergoing major non-cardiac surgery with cardiovascular risk.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Iron treatment intervention arm
|
Drug: Iron Sucrose, recombinant human erythropoietin
200mg/qod of iron sucrose by intravenous infusion and 150IU/Kg/qod of recombinant erythropoietin by subcutaneous injection from the third preoperative day to the end of the third postoperative day
|
| Placebo Comparator: Placebo control arm
|
Drug: placebo
The control group received the same dose of placebo as the experimental group, ensuring the same time, speed, conditions and methods of administration as the experimental group
|
Outcome Measures
Primary Outcome Measures
- Perioperative allogeneic red blood cell infusion rate [From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
Perioperative allogeneic red blood cell infusion rate
Secondary Outcome Measures
- Amount of allogeneic blood products used in the perioperative period [From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
(red blood cells, plasma, platelets)
- Effect of combination therapy on changes in perioperative haemoglobin levels [From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
Pre-intervention versus post-operative haemoglobin
- Effect of combination therapy on changes in perioperative ferritin levels [From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
Pre-intervention versus post-operative ferritin
- Effect of combination therapy on changes in perioperative reticulocyte levels [From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
Magnitude of reticulocyte elevation
- Incidence of perioperative acute renal insufficiency [From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
Postoperative creatinine more than 2 times higher than preoperative or oliguria (<0.5ml/kg/h) within 12 hours
- Incidence of post-operative transfer to ICU unit [From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
Incidence and Length of stay in ICU after surgery
- Infusion reactions and allergies [From the start of surgery until hospital discharge or postoperative day 30, whichever comes first]
Perioperative allergic events
- Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery [Through study completion, an average of 1.5 year]
Myocardial infarction、Ischemic cerebral infarction、arrhythmia、Deep vein thrombosis of the lower extremity、Pulmonary embolism, etc
- All-cause mortality within 6 months of surgery [Through study completion, an average of 1.5 year]
Incidence of mortality
- Total length of hospital stay [Through study completion, an average of 1 year]
Total length of hospital stay
- Incidence of perioperative infections [Through study completion, an average of 1 year]
Non-prophylactic use of antibiotics
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years and above
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Ferritin <300µg/L, transferrin saturation <20%, Hb <130g/L in men or Hb <120g/L in women
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Patients assessed as being at cardiovascular risk by the anaesthesia clinic （RCRI ≥ 1 point）
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Major elective non-cardiac surgery: Abdominal surgery: radical resection of upper digestive tract and colorectal tumors, radical resection of pancreatic duodenal tumors, etc. Orthopedics: fracture trauma, large joint replacement, scoliosis correction, radical resection of bone tumor, etc.
Exclusion Criteria:
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Allergy or contraindication to iron sucrose or recombinant human erythropoietin
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Patients with body temperature >37.5 ℃ or using non-prophylactic antibiotics
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Pregnancy or lactation
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Weight 50 kg or less
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Minimally invasive (laparoscopic, arthroscopic, etc.) surgery
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Chronic liver disease and/or screening alanine/aspartate transferase higher than 3 times or more of the upper limit of the normal range
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Family history of haemochromatosis or thalassaemia or transferrin saturation >50%
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Other known haematological diseases (folic acid or vitamin B12 deficiency ， hemolytic anemia, hemoglobinopathy, etc.)
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Known history of iron overload
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Critically ill patients with ASA≥4 before surgery
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History of receiving erythropoietin, blood transfusions or intravenous iron within 12 weeks prior to surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Second Affiliated Hospital of Zhejiang University Medical College | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Principal Investigator: Min Yan, Doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-0156