Clinical trial NCT03978260: Preoperative Anaemia prevaLence In surgiCal patiEnts
Official title: Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Iron-deficiency
Folic Acid Deficiency
Vitamin B 12 Deficiency
Anaemia of Renal Disease
Anemia of Chronic Inflammation
Keywords: Anemia
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: University Hospital, Angers
name: Medical University of Graz
name: Hospital del Mar
name: Hospital Hietzing
name: University of Zurich
name: Goethe University
name: Auckland City Hospital
First posted: 2019-06-07
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major surgical patients

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of preoperative anaemia
timeFrame: prior surgery
Secondary outcomes:
measure: Number of patients with red blood cell transfusion
timeFrame: 30 day
measure: Number of patient with revision
timeFrame: 90 day
measure: Number of patients with mortality
timeFrame: 90 day
measure: Re-admission
timeFrame: up to 90 days after discharge
measure: Hospital and ICU length of stay
timeFrame: 30 days
measure: Incidence of hospital-acquired anaemia
timeFrame: 30 days
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe University Hospital
state: Hessen
Study officials:
References: