Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-01-10 @ 12:25 AM
Study NCT ID:
NCT02421003
Status:
COMPLETED
Last Update Posted:
2016-08-03
First Post:
2015-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of red blood cell numeration from blood collected.', 'timeFrame': 'Between the incision and the closure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart surgery blood'], 'conditions': ['Heart Surgery']}, 'descriptionModule': {'briefSummary': "The recovered blood into the surgical site at the border of the fields, is very rich in red blood cells, due to the adjacency of the bone marrow and the sternum.\n\nThe blood recovered from the surgical site at the border of the fields, is richer in red blood cells than the bloodstream of the patient.\n\nThe recovered blood into the surgical site at the border of the fields, is not contaminated and bacteriological cultures are negative.\n\nConsequences: The recovered blood in the surgical site at the edge of fields, can be recovered in the Saver® Cell for reprocessing and re-injected into the patient.\n\nThere isn't in our knowledge of published clinical data on the volume and composition of the recovered blood in the surgical site after cardiac surgery.\n\nThe analysis of the available literature does not allow to estimate the expected outcomes us. Therefore, this study will be exploratory in nature and will aim to estimate the volume and the content of red blood cells from blood recovered, and generate clinical data to be used in subsequent confirmatory tests."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Any open heart surgery with or without extracorporeal circulation\n* Signature of informed consent\n* Affiliation to social security\n\nExclusion Criteria:\n\n* Subjects legally protected or unable to consent\n* Persons deprived of liberty\n* Cardiac Surgery extreme emergency (due to difficulties obtaining informed consent)\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT02421003', 'acronym': 'Blood-in-drape', 'briefTitle': 'Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery', 'orgStudyIdInfo': {'id': 'PI2014_843_0017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'Patients undergoing heart surgery', 'interventionNames': ['Procedure: heart surgery']}], 'interventions': [{'name': 'heart surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Gilles TOUATI, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}