Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-01 @ 10:01 AM
Study NCT ID:
NCT02677818
Status:
WITHDRAWN
Last Update Posted:
2022-04-04
First Post:
2016-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Clotting Factor VIII and Bleeding Adverse Reactions in Patients Under the Therapies of Thrombolysis, Anticoagulation and Anti-platelet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020521', 'term': 'Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The levels of FVIII are measured by enzyme-linked immuno sorbent assay.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plasma Factor VIII Levels', 'Ischemic stroke', 'Antithrombotic therapy', 'Bleeding'], 'conditions': ['Bleeding', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Plasma Factor VIII Levels are related to the treatment of bleeding in ischemic stroke（IS）.', 'detailedDescription': 'Clear cerebral infarction patients during hospitalization, treatment process, discharge and hemorrhage occurs, the stages F VIII level change and its correlation with bleeding adverse reactions. Analysis F VIII whether belong to hemorrhage occurs independent risk factors of adverse drug reactions,as well as the feasibility of predicting bleeding occurred adverse reaction index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The stroke patient using Anti-thrombotic drugs diagnosed by Zhujiang Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Guidelines prepared by the diagnostic criteria(according to the diagnostic criteria of the Fourth National Stroke Conference prepared,have been more than one times skull CT and/or MRI)was confirmed for ischemic stroke,and requires the use of antithrombotic therapy(including thrombolysis, anticoagulation, antiplatelet) patients\n* Willing and able to comply with the study protocol and visits planned\n\nExclusion Criteria:\n\n* At the same time the presence of other active malignancy.\n* There is known brain metastases or leptomeningeal metastases\n* Systemic active infection ( ie infection leads to body temperature ≥38 ℃)\n* The last 4 weeks there is a need drainage ascites, pleural effusion or pericardial fluid .\n* Clinically significant obstruction , pulmonary fibrosis , kidney failure , liver failure and other diseases.\n* Uncontrolled diabetes.\n* Severe / unstable angina, New York Heart Association (NYHA) class III or IV symptoms of congestive heart failure\n* there is other reason (not the antithrombotic drugs) caused by bleeding.\n* The presence of an autoimmune disease or a history of organ transplant patients require immunosuppressive therapy\n* Psychiatric presence may increase the risks associated with study participation or study drug , or may interfere with the interpretation of study results\n* Pregnant and lactating women\n* Bleeding disorders may exist on admission\n* The researchers added that the study is not appropriate to the circumstances'}, 'identificationModule': {'nctId': 'NCT02677818', 'briefTitle': 'The Relationship Between Clotting Factor VIII and Bleeding Adverse Reactions in Patients Under the Therapies of Thrombolysis, Anticoagulation and Anti-platelet', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'orgStudyIdInfo': {'id': '2014-YXB-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'experimental group', 'description': 'The risk of bleeding adverse reactions when FVIII below the normal level.'}, {'label': 'control group', 'description': 'The risk of bleeding adverse reactions when FVIII in normal level.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yong Wang, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'clinical drug trial institution'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangdong Province, Department of Science and Technology', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}