Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT03978260
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Anaemia prevaLence In surgiCal patiEnts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D005494', 'term': 'Folic Acid Deficiency'}, {'id': 'D014806', 'term': 'Vitamin B 12 Deficiency'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of preoperative anaemia', 'timeFrame': 'prior surgery', 'description': 'Hemoglobin level'}], 'secondaryOutcomes': [{'measure': 'Number of patients with red blood cell transfusion', 'timeFrame': '30 day', 'description': 'Amount of transfused units per patient'}, {'measure': 'Number of patient with revision', 'timeFrame': '90 day', 'description': 'Number of patients with Revision after surgery'}, {'measure': 'Number of patients with mortality', 'timeFrame': '90 day', 'description': 'in-hospital'}, {'measure': 'Re-admission', 'timeFrame': 'up to 90 days after discharge', 'description': 'Re-admission rates up to 90 days'}, {'measure': 'Hospital and ICU length of stay', 'timeFrame': '30 days', 'description': 'Time from Admission till discharge'}, {'measure': 'Incidence of hospital-acquired anaemia', 'timeFrame': '30 days', 'description': 'Hemoglobin level'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia'], 'conditions': ['Anemia', 'Iron-deficiency', 'Folic Acid Deficiency', 'Vitamin B 12 Deficiency', 'Anaemia of Renal Disease', 'Anemia of Chronic Inflammation']}, 'referencesModule': {'references': [{'pmid': '41240945', 'type': 'DERIVED', 'citation': 'Choorapoikayil S, Baron DM, Spahn DR, Lasocki S, Boryshchuk D, Yeghiazaryan L, Posch M, Bisbe E, Metnitz P, Reichmayr M, Zacharowski K, Meybohm P; German Society of Anaesthesiology and Intensive Care (GSAIC) Trials Group; SFAR research network; Supportive Anaesthesia Trainee-led Audit and Research Network (SATURN); ALICE study collaborators. The aetiology and prevalence of preoperative anaemia in patients undergoing major surgery (ALICE): an international, prospective, observational cohort study. Lancet Glob Health. 2025 Dec;13(12):e2041-e2050. doi: 10.1016/S2214-109X(25)00320-1.'}]}, 'descriptionModule': {'briefSummary': 'Preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality.\n\nAnaemia 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Major surgical patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent prior to study participating according to the national law requirements\n* Patients undergoing major surgery\n* Expected hospital stay with a minimum of 24 hours\n\nExclusion Criteria:\n\n* Preoperative autologous blood donation\n* Patients with expected re-surgery within the planned 7-day recruitment period'}, 'identificationModule': {'nctId': 'NCT03978260', 'acronym': 'ALICE', 'briefTitle': 'Preoperative Anaemia prevaLence In surgiCal patiEnts', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE)', 'orgStudyIdInfo': {'id': 'E35/19'}}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Johann Wolfgang Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, {'name': 'Medical University of Graz', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Hospital Hietzing', 'class': 'OTHER'}, {'name': 'University of Zurich', 'class': 'OTHER'}, {'name': 'Goethe University', 'class': 'OTHER'}, {'name': 'Auckland City Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Patrick Meybohm, M.D.', 'investigatorAffiliation': 'Wuerzburg University Hospital'}}}}