Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
Study NCT ID:
NCT04100395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2019-09-24
First Post:
2019-09-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2032-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2019-09-20', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'global monitoring of coagulation profile', 'timeFrame': 'baseline', 'description': 'Viscoelastic hemostatic assays devices have practical advantages as point-of-care devices for monitoring major hemorrhage including speed of results and a set of parameters that assesses a global coagulation profile'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Study of Hemostatic Profile in Traumatic Patients']}, 'descriptionModule': {'briefSummary': '1. Analyzing the effects of severe trauma using sonoclot analyzer (which depicts the entire hemostatic pathway) ,subsequently describing the convenient therapy .\n2. Assessing the correlations between sonoclot variables and conventional coagulation and platelet function tests', 'detailedDescription': 'Coagulopathy is a physiological response to massive bleeding that frequently occurs after severe trauma and is an independent predictive factor for mortality\\[2\\]. . There are two of the major causes of coagulopathy in trauma patients\n\n1. coagulopathy secondary to hemorrhagic shock due to massive bleeding and\n2. coagulopathy secondary to severe head injury\\[3\\] which results in release of tissue factor from damaged brain tissue.\n\nTherefore, it is very important to grasp the coagulation status of patients with severe trauma quickly and accurately with objective indicator in order to establish the therapeutic strategy .\n\nThe importance of viscoelastic devices in understanding the disease condition of patients with traumatic coagulopathy has been widely recognized in Europe. Viscoelastic hemostatic assays devices have practical advantages as point-of-care devices for monitoring major hemorrhage including speed of results and a set of parameters that assesses a global coagulation profile .\n\nAlso In the USA, Massive Transfusion in Trauma Guidelines proposed by the American College of Surgeons in 2013 presented the test results obtained by the viscoelastic devices, as the standard for transfusion or injection of blood plasma, cryoprecipitate, platelet concentrate, or anti-fibrinolytic agents in the treatment strategy for traumatic coagulopathy and hemorrhagic shock .\n\nHowever, some studies have reported limitations of these viscoelastic devices'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study will be done on patients sample', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -Patients \\>18 years.\n* Both sexes will be included.\n* Recent trauma\n\nExclusion Criteria:\n\n* -patients \\<18 years.\n* Patients with documented evidence of coagulopathy or bleeding diocese .\n* Patients with liver disease.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT04100395', 'briefTitle': 'Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Global Hemostasis Monitoring in Patients With Severe Trauma Using Sonoclot Signature Compared to Conventional Coagulation and Platelet Parameters', 'orgStudyIdInfo': {'id': 'sonoclot signature'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sonoclot', 'type': 'DEVICE', 'description': 'Sonoclot Analyzer is best described as a microviscometer. The electronics are sensitive to any resistance to motion that the oscillating probe encounters as it moves within the test sample.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dalia Hesham, master', 'role': 'CONTACT', 'email': 'daliahesham17793@yahoo.com', 'phone': '01149936172'}, {'name': 'Nabila Thabet', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident physician', 'investigatorFullName': 'DO Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}