AnemiaALICENCT03978260
Preoperative Anaemia prevaLence In surgiCal patiEnts
An observational study of Anemia and Iron-deficiency, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron-deficiency, Folic Acid Deficiency
- How many people
- 2,500 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major surgical patients
Who may be able to join
- 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
Who cannot join
- Preoperative autologous blood donation
- Patients with expected re-surgery within the planned 7-day recruitment period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Hesse, 60590
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia, Iron-deficiency, Folic Acid Deficiency, Vitamin B 12 Deficiency, Anaemia of Renal Disease, Anemia of Chronic Inflammation
- Keywords
- Anemia
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency, Folic Acid Deficiency, Vitamin B 12 Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of preoperative anaemia
Hemoglobin level
Measured: prior surgery
Secondary outcomes (6)
Number of patients with red blood cell transfusion
Amount of transfused units per patient
Measured: 30 day
Number of patient with revision
Number of patients with Revision after surgery
Measured: 90 day
Number of patients with mortality
in-hospital
Measured: 90 day
Re-admission
Re-admission rates up to 90 days
Measured: up to 90 days after discharge
Hospital and ICU length of stay
Time from Admission till discharge
Measured: 30 days
Incidence of hospital-acquired anaemia
Hemoglobin level
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start15 Aug 2019
- Primary completion30 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna, University Hospital, Angers, Medical University of Graz, Hospital del Mar, Hospital Hietzing, University of Zurich, Goethe University, Auckland City Hospital
- Responsible party
- Principal investigator, Dr. Patrick Meybohm, M.D., Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978260
- Sponsor's protocol ID
- E35/19
- Acronym
- ALICE
- Status last verified
- Aug 2025
- First submitted
- 23 May 2019
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41240945
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE)
- ClinicalTrials.gov ID
- NCT03978260
- Acronym / sponsor ID
- ALICE / E35/19
- Conditions
- Anemia, Iron-deficiency, Folic Acid Deficiency, Vitamin B 12 Deficiency, Anaemia of Renal Disease, Anemia of Chronic Inflammation
- Keywords
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Medical University of Vienna, University Hospital, Angers, Medical University of Graz, Hospital del Mar, Hospital Hietzing, University of Zurich, Goethe University, Auckland City Hospital
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major surgical patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Preoperative autologous blood donation
- Patients with expected re-surgery within the planned 7-day recruitment period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of preoperative anaemia
Time frame: prior surgery
Hemoglobin level
6 secondary outcomes
Number of patients with red blood cell transfusion
Time frame: 30 day
Number of patient with revision
Time frame: 90 day
Number of patients with mortality
Time frame: 90 day
Re-admission
Time frame: up to 90 days after discharge
Hospital and ICU length of stay
Time frame: 30 days
Incidence of hospital-acquired anaemia
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Derived from this study: PubMed 41240945Choorapoikayil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Iron-deficiency, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of preoperative anaemia (time frame: prior surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.