Clinical Trials Directory

Trials / Completed

CompletedNCT03978260

Preoperative Anaemia prevaLence In surgiCal patiEnts

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

Status
Completed
Phase
Study type
Observational
Enrollment
2,500 (actual)
Sponsor
Johann Wolfgang Goethe University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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

Timeline

Start date
2019-08-15
Primary completion
2022-12-30
Completion
2023-12-31
First posted
2019-06-07
Last updated
2025-08-07

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03978260. Inclusion in this directory is not an endorsement.