Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-28 @ 6:17 PM
Study NCT ID:
NCT04484233
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2020-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-07-18', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average global score obtained for the two groups.', 'timeFrame': 'Up to 24 weeks', 'description': 'The mean number of correct answers (out of possible 10);'}], 'secondaryOutcomes': [{'measure': 'Average subcategories score obtained for the two groups.', 'timeFrame': 'Up to 24 weeks', 'description': 'The mean number of correct answers (out of possible 10);'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Clinical Decision Support Systems', 'Patient Blood Management', 'Preoperative Anemia'], 'conditions': ['Decision Support Systems', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '30860564', 'type': 'BACKGROUND', 'citation': 'Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.'}, {'pmid': '17302768', 'type': 'BACKGROUND', 'citation': 'Rothschild JM, McGurk S, Honour M, Lu L, McClendon AA, Srivastava P, Churchill WH, Kaufman RM, Avorn J, Cook EF, Bates DW. Assessment of education and computerized decision support interventions for improving transfusion practice. Transfusion. 2007 Feb;47(2):228-39. doi: 10.1111/j.1537-2995.2007.01093.x.'}, {'pmid': '21502229', 'type': 'BACKGROUND', 'citation': 'Adams ES, Longhurst CA, Pageler N, Widen E, Franzon D, Cornfield DN. Computerized physician order entry with decision support decreases blood transfusions in children. Pediatrics. 2011 May;127(5):e1112-9. doi: 10.1542/peds.2010-3252. Epub 2011 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'Anemia need to be diagnosed and treated, following several guidelines. However, the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion.\n\nIn order to improve practices and regarding the complexity of the guidelines, the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia.', 'detailedDescription': 'The World Health Organization defines anemia as a hemoglobin level of less than 13 g/dL in adult men and less than 12 g/dL in women.\n\nThe cause of these anemias is most often deficient with 17% iron deficiency. This deficiency is related to age, inflammatory diseases, blood loss, and absorption disorders mainly. Anemia must be diagnosed preoperatively and treated.\n\nTo reduce transfusion in the perioperative period there are various possibilities: increase of the preoperative erythrocyte mass, reduction of losses, use of the blood that has been applied.\n\nThe impact of these preoperative strategies can be considerable. In their work, Beattie and al demonstrates that transfusion is associated with an increase in mortality at 90 days, proportional to the volume transfused, with certainly a higher risk in fragile subjects. More recently, an American registry of more than 220,000 patients showed that 30% had preoperative anemia. This anemia not only significantly increased mortality, but all causes of comorbidity were aggravated in an anemic patient.\n\nHowever, the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion.\n\nIn order to improve practices and regarding the complexity of the guidelines, the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Anesthesiologist:\n\n* Less than one year experience in anesthesia\n* 2 to 5 years of experience\n* 5 to 10 years of experience\n* 10 to 20 years of experience\n* More than 20 years of experience', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anesthesiologist: anesthesiologists, resident/fellow physician anesthesiologists.\n\nExclusion Criteria:\n\n* Unfinished questionnaire.'}, 'identificationModule': {'nctId': 'NCT04484233', 'acronym': 'iAnemia', 'briefTitle': 'Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intelligence Anesthesia'}, 'officialTitle': 'Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care: Feasibility & Validation Study', 'orgStudyIdInfo': {'id': 'IRB 00010254-2020-131'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management.'}, {'label': 'Clinical Decision Support Group', 'description': 'Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management helped by dedicated clinical decision support systems for patient blood management (iAnemia, Intelligence Anesthesia).', 'interventionNames': ['Device: iAnemia Decision Support System']}], 'interventions': [{'name': 'iAnemia Decision Support System', 'type': 'DEVICE', 'description': 'iAnemia permits to display the appropriate guideline using several inputs about a patient: age, type and delay of the surgery, gender, hemoglobin level, and iron deficiency status.', 'armGroupLabels': ['Clinical Decision Support Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yassine Moussali, MD', 'role': 'CONTACT', 'email': 'y.moussali@intelligenceanesthesia.com', 'phone': '+33620858135'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intelligence Anesthesia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}