Preoperative Anaemia prevaLence In surgiCal patiEnts

NCT ID: NCT03978260

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-15

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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. 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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role collaborator

Hospital del Mar

OTHER

Sponsor Role collaborator

Hospital Hietzing

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role collaborator

Auckland City Hospital

OTHER_GOV

Sponsor Role collaborator

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Patrick Meybohm, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johann Wolfgang Goethe University Hospital

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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E35/19

Identifier Type: -

Identifier Source: org_study_id

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