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Completed

NCT Number: NCT03978260

Preoperative Anaemia prevaLence In surgiCal patiEnts

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.

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Key information

Conditions

Anemia Anaemia of Renal Disease Anemia of Chronic Inflammation Anemia, Hypochromic Anemia, Iron-Deficiency Avitaminosis Deficiency Diseases Folic Acid Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Iron-deficiency Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johann Wolfgang Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of preoperative anaemia

    Time frame: prior surgery

    Hemoglobin level

Secondary outcomes

  1. Number of patients with red blood cell transfusion

    Time frame: 30 day

    Amount of transfused units per patient

  2. Number of patient with revision

    Time frame: 90 day

    Number of patients with Revision after surgery

  3. Number of patients with mortality

    Time frame: 90 day

    in-hospital

  4. Re-admission

    Time frame: up to 90 days after discharge

    Re-admission rates up to 90 days

  5. Hospital and ICU length of stay

    Time frame: 30 days

    Time from Admission till discharge

  6. Incidence of hospital-acquired anaemia

    Time frame: 30 days

    Hemoglobin level

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Collaborators

  • Auckland City Hospital
  • Goethe University
  • Hospital Hietzing
  • Hospital del Mar
  • Medical University of Graz
  • Medical University of Vienna
  • University Hospital, Angers
  • University of Zurich

Registry information

Official study title

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

Acronym: ALICE

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2019
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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