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

Withdrawn

• Conditions: Bleeding; Ischemic Stroke

• Registration Number: NCT02677818
• Lead Sponsor: Zhujiang Hospital

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.

Study Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-09
• Study Start: 2016-05
• Primary Completion: 2018-01
• Status Verified: 2021-07
• Study Completion: 2021-08
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The levels of FVIII are measured by enzyme-linked immuno sorbent assay.	one year

Trial Locations

Locations (1)

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China