Management of TA in VaS-Patients and HT

January 25, 2021 updated by: Xijing Hospital

Management of Therapeutic Antithrombotic in Patients With VTE After Stroke and Hemorrhagic Tendency

Stroke is an independent risk factor for venous thrombosis (VTE), which leads to a significant increase in the mortality and disability rate after stroke. For patients with high risk factors for VTE such as advanced age, paralysis, infection, dehydration, etc., the incidence of death and disability is higher. Studies have shown that the incidence of deep vein thrombosis in bedridden ischemic stroke patients is about 20%, and the incidence of pulmonary embolism is about 2%, and causes 10% of post-stroke deaths. In order to prevent the occurrence of VTE, the American Heart Association, the American Stroke Association, the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association, etc. pointed out in the guidelines that heparin or low molecular weight heparin should be used for stroke patients with "restricted mobility" or "incapable mobility" to prevent VTE. For patients with evidence of thrombosis or symptoms of DVT, antithrombotic therapy should be initiated immediately. Paradoxically, ischemic stroke significantly increases the risk of cerebral hemorrhage. Besides There is an increased risk of primary intracerebral hemorrhage (ICH) associated with aspirin or antiplatelet agent monotherapy and it is difficult to achieve a balance between preventing blood clots and reducing the risk of bleeding complications. In addition, stroke patients are elderly and have speech and intellectual impairment, and the non-specific symptoms and signs of intracranial hemorrhage caused by improper antithrombotic therapy make the rate of misdiagnosis and missed diagnosis extremely high. Therefore, clarifying the clinical characteristics of stroke patients with VTE and launching targeted interventions to effectively balance the risk of anti-thrombosis and bleeding have become the key to improving the prognosis of patients.

This study is based on real-world data to study the bleeding risk and antithrombotic treatment options in VaS (1) the risk factors associated with hemorrhage in patients with VTE after stroke; and (2) the characteristics and pharmacotherapeutics regimen of high-risk populations with VTE after stroke; and(3) the Optimal antithrombotic treatment regimen for patients with VTE after stroke, including the timing of starting and stopping the antithrombotic treatment, selection of varieties, dosage, and course of treatment, etc.

Study Overview

Status

Unknown

Conditions

VTE After Stroke

Intervention / Treatment

Drug: Antithrombotic Agents

Study Type

Observational

Enrollment (Anticipated)

1500

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
- Shaanxi
  - Xi'an, Shaanxi, China, 710000
    - The First Affiliated Hospital of the Air Force 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

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We integrated pooled individual patient data of consecutive VaS patients treated at a single center (Departments of Neurology) in China from 1 January 2008 until 31 December 2020.

Description

Inclusion Criteria:

Patients diagnosed with VTE after stroke
Use at least one antithrombotic drug

Exclusion Criteria:

Case information is incomplete
Non-spontaneous cerebral hemorrhage
Suffer from serious blood system disease
Do not accept follow-up

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications during hospital stay in patients with VTE after stroke Time Frame: Through study completion, an average of 2 weeks.	Bleeding is defined as intracranial hemorrhage and non-intracranial hemorrhage, and thrombosis is defined as aggravated or new thrombosis.	Through study completion, an average of 2 weeks.

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Investigators

Study Director: Jingwen Wang, The First Affiliated Hospital of the Air Force Medical University

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 (ACTUAL)

January 1, 2018

Primary Completion (ANTICIPATED)

February 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (ACTUAL)

January 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)