Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-03-06 @ 6:14 PM
Study NCT ID:
NCT02902393
Status:
UNKNOWN
Last Update Posted:
2016-09-15
First Post:
2016-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013916', 'term': 'Thrombelastography'}], 'ancestors': [{'id': 'D001780', 'term': 'Blood Coagulation Tests'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Clinical evaluation using NIHSS scale', 'timeFrame': '24 hours'}]}, 'conditionsModule': {'keywords': ['Fibrinolysis', 'tPA'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy.\n\nThe aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients meeting the eligibility criteria will be invited to participate in the study . Patients will be recruited to emergencies CHU Caen and Saint Joseph Hospital. The goal is to recruit patients with neurological defect consistent with a neurovascular pathology eligible for thrombolysis with tPA.\n\nWith the admission of patients, blood samples are routinely made . For this study, the investigators will add one citrated 5 mL tube. An information letter and consent form will be given to the patient.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient (\\> 18 years) with a neurological deficit compatible with a neurovascular pathology eligible for fibrinolysis rtPA and having a proximal occlusion of the middle cerebral artery (segment M1 / M2) or basilar trunk objectified brain imaging (MRI angiography or angio CT).\n\nExclusion Criteria:\n\n* Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).'}, 'identificationModule': {'nctId': 'NCT02902393', 'acronym': 'ROTEMPredict', 'briefTitle': 'Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke', 'orgStudyIdInfo': {'id': '15-202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Success of revascularisation', 'interventionNames': ['Biological: Thromboelastography']}], 'interventions': [{'name': 'Thromboelastography', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Success of revascularisation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Calvados', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe Kassel', 'role': 'CONTACT', 'email': 'directiongenerale@chu-caen.fr', 'phone': '0231063106', 'phoneExt': '+33'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Yohann REPESSE, MD PhD', 'role': 'CONTACT', 'email': 'repesse-y@chu-caen.fr', 'phone': '+330231063315'}], 'overallOfficials': [{'name': 'Richard MACREZ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}