Preoperative Anaemia prevaLence In surgiCal patiEnts

Completed

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

• Registration Number: NCT03978260
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-07
• Study Start: 2019-08-15
• Primary Completion: 2022-12-30
• Status Verified: 2023-09
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of preoperative anaemia	prior surgery	Hemoglobin level

Secondary Outcome Measures

Name	Time	Method
Re-admission	up to 90 days after discharge	Re-admission rates up to 90 days
Number of patients with red blood cell transfusion	30 day	Amount of transfused units per patient
Number of patient with revision	90 day	Number of patients with Revision after surgery
Number of patients with mortality	90 day	in-hospital
Hospital and ICU length of stay	30 days	Time from Admission till discharge
Incidence of hospital-acquired anaemia	30 days	Hemoglobin level

Trial Locations

Locations (1)

Johann Wolfgang Goethe University Hospital; 🇩🇪 Frankfurt am Main, Hessen, Germany