NCT03310931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

October 11, 2017

Last Update Submit

October 11, 2017

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • END

    increase of NIHSS \>=2

    fist week after admission

Secondary Outcomes (1)

  • DWI lesion growth

    7 days

Study Arms (1)

End and non-END groups

END was denied as NIHSS score increase of 2 or more than 2 within 7 days after admission

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguan peoples' hospital

Dongguan, Guangdong, 523029, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

thrombelastography on admission

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Deputy Director of Neurology Department

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 16, 2017

Study Start

June 1, 2016

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

CN(1)