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

Completed

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT03310931
• Lead Sponsor: Dongguan People's Hospital

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 Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2017-10
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-11
• Last Update Submitted: 2017-10-11
• Study First Posted: 2017-10-16
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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. )

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
END	fist week after admission	increase of NIHSS \>=2

Secondary Outcome Measures

Name	Time	Method
DWI lesion growth	7 days	Large volume or new lesions on followup DWI than the baseline DWI

Trial Locations

Locations (1)

Dongguan peoples' hospital; 🇨🇳 Dongguan, Guangdong, China