Management of TA in VaS-Patients and HT

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

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • The First Affiliated Hospital of the Air Force Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications during hospital stay in patients with VTE after stroke	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

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

Study record dates

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): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents
• Other Study ID Numbers: Wang JingWen-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No