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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03978260
Other study ID # E35/19
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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