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Preoperative Anaemia prevaLence In surgiCal patiEnts

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03978260
Acronym
ALICE
Enrollment
2500
Registered
2019-06-07
Start date
2019-08-15
Completion date
2023-12-31
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Anemia

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.

Interventions

None listed

Sponsors

Medical University of Vienna
CollaboratorOTHER
University Hospital, Angers
CollaboratorOTHER_GOV
Medical University of Graz
CollaboratorOTHER
Hospital del Mar
CollaboratorOTHER
Hospital Hietzing
CollaboratorOTHER
University of Zurich
CollaboratorOTHER
Goethe University
CollaboratorOTHER
Auckland City Hospital
CollaboratorOTHER_GOV
Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of preoperative anaemiaprior surgeryHemoglobin level

Secondary

MeasureTime frameDescription
Number of patient with revision90 dayNumber of patients with Revision after surgery
Number of patients with mortality90 dayin-hospital
Number of patients with red blood cell transfusion30 dayAmount of transfused units per patient
Hospital and ICU length of stay30 daysTime from Admission till discharge
Incidence of hospital-acquired anaemia30 daysHemoglobin level
Re-admissionup to 90 days after dischargeRe-admission rates up to 90 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026