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Clinical Trials/NCT03310931
NCT03310931CompletedNot Applicable

Predictive Significance of Thrombelastography on Early Neurological Deterioration in Patients With Acute Ischemic Stroke

Dongguan People's Hospital1 site in 1 country200 target enrollmentStarted: June 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
END

Study Overview

Brief Summary

The purpose of this study is to evaluate whether Thromboelastography (TEG) parameters on admission might be predictive for early neurological deterioration in acute ischemic stroke patients, specifically for the DWI lesion evolution within the first week after stroke onset.

Detailed Description

Early neurological deterioration (END ) is a major concern in stroke care, consistently associated with adverse clinical outcomes.END is a heterogeneous complex of pathophysiological and clinical entities. Despite some straight forward causes, DWI lesion growth is reportedly a primary underlying mechanism. Early recognition of END risk would allow for timely identification and proper intervention, improving stroke health care.

Thromboelastography (TEG) measures the coagulation process from initial clotting cascade to clot strength, providing an integrated picture of two separate but simultaneously occuring components of coagulation, thrombosis and lysis. It has been reported to be associated with short and long-term outcome in patients with trauma, coronary artery diseases , pulmonary embolism and, most recently, stroke prevention.The purposes of this study is to evaluate how effective TEG is on predicting END, by producing a range of TEG values correlated with clinical and radiological assessment.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • acute ischemic stroke within 24 hours after symptom onset
  • first ever stroke
  • give informed consent

Exclusion Criteria

  • receiving thrombolysis
  • cardiogenic embolism
  • contradiction to serial MRI studies
  • taking hemostatic agents (warfarin, oral anticoagulants and etc. )

Outcomes

Primary Outcomes

END

Time Frame: fist week after admission

increase of NIHSS \>=2

Secondary Outcomes

  • DWI lesion growth(7 days)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Zhu Shi

MD, Deputy Director of Neurology Department

Dongguan People's Hospital

Study Sites (1)

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