TCD Monitoring Technology Guides the Precise Control of Blood Pressure After EVT

Acute Ischemic Stroke Clinical Trial

Official title:

TCD Monitoring Technology Guides the Precise Control of Blood Pressure After EVT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03529149
• Other study ID #: [2018]007
• Status: Recruiting
• Phase: Phase 4
• Start date: April 8, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2018
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators hypothesized that the precise regulation of blood pressure based on the changes of cerebral blood flow parameters under TCD monitoring can better improve the state of cerebral blood flow, reduce the risk of early neurological deterioration and improve the prognosis of the patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older;

• accept EVT treatment within 6 hours of symptoms onset;

• In selected patients with AIS within 6 to 16 hours of last known normal who have LVO in the anterior circulation and meet other DAWN or DEFUSE 3 eligibility criteria..

• In selected patients with AIS within 6 to 24 hours of last known normal who have LVO in the anterior circulation and meet other DAWN eligibility criteria.

Exclusion Criteria:

• Pre - onset mRS>2;

• severe dementia;

• threatening life diseases (such as malignant tumor, etc.);

• non acute ischemic cerebrovascular disease patients undergoing selective intravascular treatment;

• related sound window closure can not be monitoring with TCD.

Related Conditions & MeSH terms

• Acute Ischemic Stroke

Intervention

Combination Product:
• Urapidil Hydrochloride Injection
Accurate monitoring of blood pressure is carried out under TCD monitoring, that is to maintain (mean flow velocity)MFV or (pulse index)PI target blood pressure. The target values of MFV and PI are MFV>37cm/s of (middle cerebral artery)MCA, PI < 1.34cm/s, aMFV>40cm/s of (basilar artery)BA, PI < 0.8cm/s. TCD shows that when the MFV of MCA or BA is lower than the target value, the blood pressure is reduced or discontinued according to the insufficiency of blood flow. and the current blood pressure is maintained once MFV is met. TCD showed that the PI index of MCA or BA was higher than the target value . The blood pressure reduction was treated by excessive perfusion: intravenous infusion of blood pressure drugs , once PI index is up to the standard, maintaining the current blood pressure.

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early neurological deterioration	the incidence of 72 hours in National Institute of Health stroke scale increased more than 4 points or National Institute of Health stroke scale Ia score more than 1 points	72 hours
Secondary	prognosis of nerve function	prognosis of nerve function use Modified Rankin Scale,0~3 is good prognosis and 4~6 is poor prognosis.	3 months