Anemia Clinical Trial
— ALICEOfficial title:
Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE)
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 |
Verified date | September 2023 |
Source | Johann Wolfgang Goethe University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Johann Wolfgang Goethe University Hospital | Frankfurt am Main | Hessen |
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 |
Germany,
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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