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

Predictive Significance of Thrombelastography on Early Neurological Deterioration 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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523029
      • Dongguan peoples' hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes consecutively admitted patients with acute ischemic stroke in Dongguan people's Hospital. Patients would take TEG study within 6 hours after admission, as well as other routine lab tests. Serial MRI studies would be taken on admission and followed up on 7th day afterward, except when patients experience END, in which case followup MRI should be preformed immediately.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
End and non-END groups; END was denied as NIHSS score increase of 2 or more than 2 within 7 days after admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
END	increase of NIHSS >=2	fist week after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DWI lesion growth	Large volume or new lesions on followup DWI than the baseline DWI	7 days

Collaborators and Investigators

• Sponsor: Dongguan People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: DongguanPeopleH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes