Preoperative Anaemia prevaLence In surgiCal patiEnts

Anemia Clinical Trial

— ALICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03978260
• Other study ID #: E35/19
• Status: Completed
• Start date: August 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe University Hospital	Frankfurt am Main	Hessen

Sponsors (9)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	Auckland City Hospital, Goethe University, Hospital del Mar, Hospital Hietzing, Medical University of Graz, Medical University of Vienna, University Hospital, Angers, University of Zurich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of preoperative anaemia	Hemoglobin level	prior surgery
Secondary	Number of patients with red blood cell transfusion	Amount of transfused units per patient	30 day
Secondary	Number of patient with revision	Number of patients with Revision after surgery	90 day
Secondary	Number of patients with mortality	in-hospital	90 day
Secondary	Re-admission	Re-admission rates up to 90 days	up to 90 days after discharge
Secondary	Hospital and ICU length of stay	Time from Admission till discharge	30 days
Secondary	Incidence of hospital-acquired anaemia	Hemoglobin level	30 days