Preoperative Anaemia prevaLence In surgiCal patiEnts (ALICE)
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ClinicalTrials.gov Identifier: NCT03978260 |
Recruitment Status :
Recruiting
First Posted : June 7, 2019
Last Update Posted : March 29, 2022
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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.
Condition or disease |
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Anemia Iron-deficiency Folic Acid Deficiency Vitamin B 12 Deficiency Anaemia of Renal Disease Anemia of Chronic Inflammation |
Study Type : | Observational |
Estimated Enrollment : | 1500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE) |
Actual Study Start Date : | August 30, 2019 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | December 31, 2022 |
- Prevalence of preoperative anaemia [ Time Frame: prior surgery ]Hemoglobin level
- Number of patients with red blood cell transfusion [ Time Frame: 30 day ]Amount of transfused units per patient
- Number of patient with revision [ Time Frame: 90 day ]Number of patients with Revision after surgery
- Number of patients with mortality [ Time Frame: 90 day ]in-hospital
- Re-admission [ Time Frame: up to 90 days after discharge ]Re-admission rates up to 90 days
- Hospital and ICU length of stay [ Time Frame: 30 days ]Time from Admission till discharge
- Incidence of hospital-acquired anaemia [ Time Frame: 30 days ]Hemoglobin level

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978260
Germany | |
Johann Wolfgang Goethe University Hospital | Recruiting |
Frankfurt am Main, Hesse, Germany, 60590 | |
Contact: Patrick Meybohm, Prof. Dr. +49 (0) 69 630187461 patrick.meybohm@kgu.de | |
Contact: Suma Choorapoikayil, Dr. +49 (0) 69 630183169 suma.choorapoikayil@kgu.de |
Responsible Party: | Dr. Patrick Meybohm, M.D., Principal Investigator, Johann Wolfgang Goethe University Hospital |
ClinicalTrials.gov Identifier: | NCT03978260 |
Other Study ID Numbers: |
E35/19 |
First Posted: | June 7, 2019 Key Record Dates |
Last Update Posted: | March 29, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anemia |
Anemia Vitamin B 12 Deficiency Folic Acid Deficiency Inflammation Pathologic Processes Hematologic Diseases |
Vitamin B Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |