Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-03-28 @ 7:54 PM
Study NCT ID:
NCT06493435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Patient Blood Management Protocol in Gynecological Surgery Department (PERIOPESGYNECO)
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of immediate pre operative anemia', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'preoperative Hb\\<13g/dL'}], 'secondaryOutcomes': [{'measure': 'rate of preoperative anemia that need to be treated diagnosed during anesthetic consultation', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'Hb\\<13 g/dL'}, {'measure': 'rate of Hemoglobin dosage available during anesthetic evaluation', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'number and rate of blood analyses'}, {'measure': 'rate of preoperative iron deficiency that need to be treated diagnosed during anesthetic consultation', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'blood ferritin level \\<100 ng/mL'}, {'measure': 'adequacy between diagnosed iron deficiency anemia and treatment', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'rate of iron prescription'}, {'measure': 'effectiveness of iron treatment', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'rate of persistent pre operative anemia after iron treatment'}, {'measure': 'immediat effect of surgery on anemia incidence', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'rate of post operative anemia (Hb\\<12g/dL)/ rate of post operative iron treatment'}, {'measure': 'delayed effect of surgery on anemia incidence', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'rate of delayed post operative anemia or iron deficiency'}, {'measure': 'early post operative recovery', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'FQoR 15 on the day of hospital dischage'}, {'measure': 'delayed post operative recovery', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'FQoR 15 at the post operative surgical visit'}, {'measure': 'adhesion to PBM protocol (rate of anemia)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of rate of anemia screening'}, {'measure': 'efficiency of PBM protocol (iron treatment rate)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of iron treatment rate'}, {'measure': 'adhesion to PBM protocol (missing datas)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of the rate of missing datas'}, {'measure': 'efficiency of PBM protocol (preoperative anemia rate)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of the rate of preoperative anemia'}, {'measure': 'efficiency of PBM protocol (perioperative transfusion rate)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of the rate of peri opeartive transfusion'}, {'measure': 'efficiency of PBM protocol (mean of FQoR-15)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of the mean of FQoR-15'}, {'measure': 'efficiency of PBM protocol (mean of FQoR-15 between patients with or without preoperative anemia)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of FQoR-15 means between patients with or without preoperative anemia'}, {'measure': 'efficiency of PBM protocol (rate of screening anemia and the rate of preoperative anemia )', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of the rate of screening anemia and the rate of preoperative anemia'}, {'measure': 'efficiency of PBM protocol (Hb level between anesthetic evaluation and pre anesthetic visit)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of Hb level between anesthetic evaluation and pre anesthetic visit (paired T test)'}, {'measure': 'efficiency of PBM protocol (difference of hemoglobin level after iron treatment)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'mean difference of hemoglobin level after iron treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anemia', 'perioperative period', 'post operative recovery', 'patient blood management'], 'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'Perioperative anemia is associated with higher risk of red blood cell transfusion, higher rates of morbimortality and lower quality of postoperative recovery. In a context of focussing on higher quality management and improved recovery after surgery, development of Patient Blood management has increased. This study aim to assess PBM protocole in a postoperative context of gynaecological surgery, by comparing indicators at two time periods: 2 and 8 months after establishment of PBM protocol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with planned surgery of hyterectomy or cancer related ovariectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* being hospitalised for planned hysterectomy or cancer related ovariectomy\n\nExclusion Criteria:\n\n* less than 18 years\n* non french speaker\n* being under a legal individual protection measure\n* not being able to consent\n* being opposed to data collection'}, 'identificationModule': {'nctId': 'NCT06493435', 'acronym': 'PERIOPESGYNECO', 'briefTitle': 'Efficiency of Patient Blood Management Protocol in Gynecological Surgery Department (PERIOPESGYNECO)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Evaluation du Protocole de PBM du Service de Chirurgie gynécologique du CHU d'Angers: étude Periope 2", 'orgStudyIdInfo': {'id': '24_0207'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sigismond Lasocki', 'role': 'CONTACT', 'email': 'SiLasocki@chu-angers.fr', 'phone': '0241353635', 'phoneExt': '+33'}, {'name': 'Elise Houssin', 'role': 'CONTACT', 'email': 'DRCI-Promotion-Interne@chu-angers.fr', 'phone': '02 41 35 36 37', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Sigismond Lasocki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}