Acute Ischemic StrokeNCT03310931
Predictive Significance of TEG on END in Patients With Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Dongguan People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- acute ischemic stroke within 24 hours after symptom onset
- first ever stroke
- give informed consent
Who cannot join
- receiving thrombolysis
- cardiogenic embolism
- contradiction to serial MRI studies
- taking hemostatic agents (warfarin, oral anticoagulants and etc. )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
END
increase of NIHSS >=2
Measured: fist week after admission
Secondary outcomes (1)
DWI lesion growth
Large volume or new lesions on followup DWI than the baseline DWI
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Jun 2016
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongguan People's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhu Shi, Dongguan People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310931
- Sponsor's protocol ID
- DongguanPeopleH
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Significance of Thrombelastography on Early Neurological Deterioration in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03310931
- Acronym / sponsor ID
- DongguanPeopleH
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dongguan People's HospitalOther government
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End and non-END groups | – | –END was denied as NIHSS score increase of 2 or more than 2 within 7 days after admission |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- acute ischemic stroke within 24 hours after symptom onset
- first ever stroke
- give informed consent
Key exclusion criteria (4 listed)
- receiving thrombolysis
- cardiogenic embolism
- contradiction to serial MRI studies
- taking hemostatic agents (warfarin, oral anticoagulants and etc. )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
END
Time frame: fist week after admission
increase of NIHSS >=2
1 secondary outcome
DWI lesion growth
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Dongguan People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
END (time frame: fist week after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.