The Relationship Between Clotting Factor VIII and Bleeding Adverse Reactions in Patients Under the Therapies of Thrombolysis, Anticoagulation and Anti-platelet

NCT ID: NCT02677818

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2021-08-31

Brief Summary

The purpose of this study is to determine whether Plasma Factor VIII Levels are related to the treatment of bleeding in ischemic stroke（IS）.

Detailed Description

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.

Conditions

Bleeding; Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

experimental group

The risk of bleeding adverse reactions when FVIII below the normal level.

No interventions assigned to this group

control group

The risk of bleeding adverse reactions when FVIII in normal level.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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
• Willing and able to comply with the study protocol and visits planned

Exclusion Criteria

• At the same time the presence of other active malignancy.
• There is known brain metastases or leptomeningeal metastases
• Systemic active infection ( ie infection leads to body temperature ≥38 ℃)
• The last 4 weeks there is a need drainage ascites, pleural effusion or pericardial fluid .
• Clinically significant obstruction , pulmonary fibrosis , kidney failure , liver failure and other diseases.
• Uncontrolled diabetes.
• Severe / unstable angina, New York Heart Association (NYHA) class III or IV symptoms of congestive heart failure
• there is other reason (not the antithrombotic drugs) caused by bleeding.
• The presence of an autoimmune disease or a history of organ transplant patients require immunosuppressive therapy
• Psychiatric presence may increase the risks associated with study participation or study drug , or may interfere with the interpretation of study results
• Pregnant and lactating women
• Bleeding disorders may exist on admission
• The researchers added that the study is not appropriate to the circumstances

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Province, Department of Science and Technology

OTHER_GOV

Sponsor Role: collaborator

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yong Wang, Doctor

Role: STUDY_DIRECTOR

clinical drug trial institution

Locations

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2014-YXB-001

Identifier Type: -

Identifier Source: org_study_id