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

NCT02677818 | Withdrawn

• 1 other identifier: 2014-YXB-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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）.

Conditions

Bleeding; Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The levels of FVIII are measured by enzyme-linked immuno sorbent assay.

  one year

Study Arms (2)

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.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Guangdong Province, Department of Science and Technology: collaborator

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yong Wang, Doctor

  clinical drug trial institution

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: August 1, 2021
• Last Updated: April 4, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)