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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310931
• Other study ID #: DongguanPeopleH
• Status: Completed
• Phase: N/A
• First received: October 11, 2017
• Last updated: October 11, 2017
• Start date: June 1, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2017
• Source: Dongguan People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. )

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Locations

Country	Name	City	State
China	Dongguan peoples' hospital	Dongguan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Dongguan People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	END	increase of NIHSS >=2	fist week after admission
Secondary	DWI lesion growth	Large volume or new lesions on followup DWI than the baseline DWI	7 days