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

March 22, 2022 updated by: Zhujiang Hospital
The purpose of this study is to determine whether Plasma Factor VIII Levels are related to the treatment of bleeding in ischemic stroke（IS）.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhujiang Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Collaborators

Guangdong Province, Department of Science and Technology

Investigators

  • Study Director: Yong Wang, Doctor, clinical drug trial institution

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-YXB-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Stroke

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe