Clinical trial NCT02677818: The Relationship Between Clotting Factor VIII and Bleeding Adverse Reactions in Patients Under the Therapies of Thrombolysis, Anticoagulation and Anti-platelet
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bleeding
Ischemic Stroke
Keywords: Plasma Factor VIII Levels
Ischemic stroke
Antithrombotic therapy
Bleeding
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Province, Department of Science and Technology
First posted: 2016-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The stroke patient using Anti-thrombotic drugs diagnosed by 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.

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

Primary outcomes:
measure: The levels of FVIII are measured by enzyme-linked immuno sorbent assay.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: clinical drug trial institution
name: Yong Wang, Doctor
role: STUDY_DIRECTOR
References: