Preoperative Anaemia prevaLence In surgiCal patiEnts

NCT03978260 | Completed DMC

• 1 other identifier: E35/19
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anemia

Outcome Measures

Primary Outcomes (1)

• Prevalence of preoperative anaemia

  Hemoglobin level

  prior surgery

Secondary Outcomes (6)

• Number of patients with red blood cell transfusion

  30 day

• Number of patient with revision

  90 day

• Number of patients with mortality

  90 day

• Re-admission

  up to 90 days after discharge

• Hospital and ICU length of stay

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Major surgical patients

You may qualify if:

• 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

You may not qualify if:

• Preoperative autologous blood donation
• Patients with expected re-surgery within the planned 7-day recruitment period

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead
• Medical University of Vienna: collaborator
• University Hospital, Angers: collaborator
• Medical University of Graz: collaborator
• Hospital del Mar: collaborator
• Hospital Hietzing: collaborator
• University of Zurich: collaborator
• Goethe University: collaborator
• Auckland City Hospital: collaborator

Study Sites (1)

Johann Wolfgang Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (1)

• Choorapoikayil S, Baron DM, Spahn DR, Lasocki S, Boryshchuk D, Yeghiazaryan L, Posch M, Bisbe E, Metnitz P, Reichmayr M, Zacharowski K, Meybohm P; German Society of Anaesthesiology and Intensive Care (GSAIC) Trials Group; SFAR research network; Supportive Anaesthesia Trainee-led Audit and Research Network (SATURN); ALICE study collaborators. The aetiology and prevalence of preoperative anaemia in patients undergoing major surgery (ALICE): an international, prospective, observational cohort study. Lancet Glob Health. 2025 Dec;13(12):e2041-e2050. doi: 10.1016/S2214-109X(25)00320-1.

  PMID: 41240945 DERIVED

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Folic Acid Deficiency; Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 7, 2019
• Study Start: August 15, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2023
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)