Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,500
- Locations
- 1
- Primary Endpoint
- Prevalence of preoperative anaemia
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Prevalence of preoperative anaemia
Time Frame: prior surgery
Hemoglobin level
Secondary Outcomes
- Re-admission(up to 90 days after discharge)
- Number of patients with red blood cell transfusion(30 day)
- Number of patient with revision(90 day)
- Number of patients with mortality(90 day)
- Hospital and ICU length of stay(30 days)
- Incidence of hospital-acquired anaemia(30 days)
Investigators
Dr. Patrick Meybohm, M.D.
Principal Investigator
Wuerzburg University Hospital