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Completed

NCT Number: NCT03310931

Predictive Significance of TEG on END in Patients With Acute Ischemic Stroke

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongguan peoples' hospital

Dongguan, Guangdong, 523029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. )

Treatment and study plan

Primary outcomes

  1. END

    Time frame: fist week after admission

    increase of NIHSS >=2

Secondary outcomes

  1. DWI lesion growth

    Time frame: 7 days

    Large volume or new lesions on followup DWI than the baseline DWI

Sponsors and collaborators

Lead sponsor

Dongguan People's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2017
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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