The Relationship Between Clotting Factor VIII and Bleedin... | NCT02677818

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

NCT02677818

Sponsor

Zhujiang Hospital

Status

Withdrawn

Last Update Posted

Apr 4, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Bleeding
Ischemic Stroke

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Jan 2018Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Feb 5, 2016

First Submission Date that Met QC Criteria

Feb 5, 2016

First Posted Date

Feb 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2022

Last Update Posted Date

Apr 4, 2022Actual

Name	Class
Guangdong Province, Department of Science and Technology	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group		The risk of bleeding adverse reactions when FVIII below the normal level.
control group		The risk of bleeding adverse reactions when FVIII in normal level.

Interventions

Not provided

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

The stroke patient using Anti-thrombotic drugs diagnosed by Zhujiang Hospital.

Sampling Method

Probability Sample

ID	Term
D006470	Hemorrhage
D000083242	Ischemic Stroke

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D020521	Stroke
D002561	Cerebrovascular Disorders