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出境医 / 临床实验 / Preoperative Anaemia prevaLence In surgiCal patiEnts (ALICE)
Preoperative Anaemia prevaLence In surgiCal patiEnts (ALICE)
Study Description
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.
Study Design
| 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) |
| Actual Study Start Date : | August 30, 2019 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | January 31, 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Prevalence of preoperative anaemia [ Time Frame: prior surgery ]Hemoglobin level
Secondary Outcome Measures :
- Number of patients with red blood cell transfusion [ Time Frame: 30 day ]Amount of transfused units per patient
- Number of patient with revision [ Time Frame: 90 day ]Number of patients with Revision after surgery
- Number of patients with mortality [ Time Frame: 90 day ]in-hospital
- Re-admission [ Time Frame: up to 90 days after discharge ]Re-admission rates up to 90 days
- Hospital and ICU length of stay [ Time Frame: 30 days ]Time from Admission till discharge
- Incidence of hospital-acquired anaemia [ Time Frame: 30 days ]Hemoglobin level
Eligibility Criteria
| 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
Contacts and Locations
Locations
| 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
Hospital Universitari del Mar de Barcelona
Royal Marsden NHS Foundation Trust
Hospital Hietzing
University of Zurich
University Hospital, Frankfurt
Auckland City Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 23, 2019 | ||||
| First Posted Date | June 7, 2019 | ||||
| Last Update Posted Date | February 5, 2021 | ||||
| Actual Study Start Date | August 30, 2019 | ||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Prevalence of preoperative anaemia [ Time Frame: prior surgery ] Hemoglobin level
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Preoperative Anaemia prevaLence In surgiCal patiEnts | ||||
| Official Title | Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE) | ||||
| 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. |
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| 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 Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Major surgical patients | ||||
| Condition |
|
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
1500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | January 31, 2022 | ||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | |||||
| Listed Location Countries | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03978260 | ||||
| Other Study ID Numbers | E35/19 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital | ||||
| Study Sponsor | Johann Wolfgang Goethe University Hospital | ||||
| Collaborators |
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| Investigators | Not Provided | ||||
| PRS Account | Johann Wolfgang Goethe University Hospital | ||||
| Verification Date | February 2021 | ||||
