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

Ischemic Stroke Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02677818
• Other study ID #: 2014-YXB-001
• Status: Withdrawn
• Start date: May 2016
• Est. completion date: August 2021

Study information

• Verified date: July 2021
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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）.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2021
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Ischemic Stroke

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	Guangdong Province, Department of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The levels of FVIII are measured by enzyme-linked immuno sorbent assay.		one year