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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02677818

Enrollment

Registered

2016-02-09

Start date

2016-05-31

Completion date

2021-08-31

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Ischemic Stroke

Keywords

Plasma Factor VIII Levels, Ischemic stroke, Antithrombotic therapy, Bleeding

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Outcome results