Preoperative Anaemia prevaLence In surgiCal patiEnts

Study Overview
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Brief Summary
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Preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality. Anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin B12 or folate, and bone marrow diseases. Among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. The aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin B12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery.

Detailed Description
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Preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality. Due to the potential risk of additional blood loss, anaemia represents a serious disease condition within the surgical field. Especially patients undergoing major elective surgery are at risk of substantial blood loss. Anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin B12 or folate, and bone marrow diseases. Among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. The aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin B12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery. Results will facilitate design of supplementation strategies to improve haemoglobin level before surgery.

Official Title
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Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE)

Conditions
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Anemia, Iron-deficiency, Folic Acid Deficiency, Vitamin B 12 Deficiency, Anaemia of Renal Disease, Anemia of Chronic Inflammation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Written informed consent prior to study participating according to the national law requirements Patients undergoing major surgery Expected hospital stay with a minimum of 24 hours Exclusion Criteria: Preoperative autologous blood donation Patients with expected re-surgery within the planned 7-day recruitment period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of preoperative anaemia | Hemoglobin level | prior surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with red blood cell transfusion | Amount of transfused units per patient | 30 day | 
| Number of patient with revision | Number of patients with Revision after surgery | 90 day | 
| Number of patients with mortality | in-hospital | 90 day | 
| Re-admission | Re-admission rates up to 90 days | up to 90 days after discharge | 
| Hospital and ICU length of stay | Time from Admission till discharge | 30 days | 
| Incidence of hospital-acquired anaemia | Hemoglobin level | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia