Preoperative Anaemia prevaLence In surgiCal patiEnts (ALICE)

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

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Anemia; Vitamin B 12 Deficiency; Folic Acid Deficiency; Anaemia of Renal Disease; Anemia of Chronic Inflammation

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 Type: Observational
• Enrollment (Actual): 2500

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Johann Wolfgang Goethe University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Major surgical patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Collaborators: Medical University of Graz; University Hospital, Angers; Medical University of Vienna; University of Zurich; Goethe University; Hospital del Mar; Hospital Hietzing; Auckland City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 3, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Anemia
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Metabolic Diseases; Hematologic Diseases; Iron Metabolism Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Iron Deficiencies; Inflammation; Anemia; Folic Acid Deficiency; Vitamin B 12 Deficiency
• Other Study ID Numbers: E35/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No