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Preoperative Anaemia prevaLence In surgiCal patiEnts (ALICE)

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ClinicalTrials.gov Identifier: NCT03978260
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborators:
Medical University of Vienna
University Hospital, Angers
Medical University of Graz
University of Malaga
Royal Marsden NHS Foundation Trust
Hospital Hietzing
St George's University Hospitals NHS Foundation Trust
University of Giessen
University of Zurich
RWTH Aachen University
University Hospital, Frankfurt
Information provided by (Responsible Party):
Dr. Patrick Meybohm, M.D., 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.


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

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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE)
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia




Primary Outcome Measures :
  1. Prevalence of preoperative anaemia [ Time Frame: prior surgery ]
    Hemoglobin level


Secondary Outcome Measures :
  1. Number of patients with red blood cell transfusion [ Time Frame: 30 day ]
    Amount of transfused units per patient

  2. Number of patient with revision [ Time Frame: 90 day ]
    Number of patients with Revision after surgery

  3. Number of patients with mortality [ Time Frame: 90 day ]
    in-hospital

  4. Re-admission [ Time Frame: up to 90 days after discharge ]
    Re-admission rates up to 90 days

  5. Hospital and ICU length of stay [ Time Frame: 30 days ]
    Time from Admission till discharge

  6. Incidence of hospital-acquired anaemia [ Time Frame: 30 days ]
    Hemoglobin level



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Major surgical patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978260


Locations
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Germany
Johann Wolfgang Goethe University Hospital Recruiting
Frankfurt am Main, Hesse, Germany, 60590
Contact: Patrick Meybohm, Prof. Dr.    +49 (0) 69 630187461    patrick.meybohm@kgu.de   
Contact: Suma Choorapoikayil, Dr.    +49 (0) 69 630183169    suma.choorapoikayil@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Medical University of Vienna
University Hospital, Angers
Medical University of Graz
University of Malaga
Royal Marsden NHS Foundation Trust
Hospital Hietzing
St George's University Hospitals NHS Foundation Trust
University of Giessen
University of Zurich
RWTH Aachen University
University Hospital, Frankfurt

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Responsible Party: Dr. Patrick Meybohm, M.D., Principal Investigator, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03978260     History of Changes
Other Study ID Numbers: E35/19
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital:
Anemia
Additional relevant MeSH terms:
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Anemia
Vitamin B 12 Deficiency
Folic Acid Deficiency
Inflammation
Pathologic Processes
Hematologic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders