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

NCT ID: NCT03529149

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-08
• Study Completion Date: 2019-06-01

Brief 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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Accurate blood pressure control

Implementing accurate blood pressure management under TCD monitoring

Group Type: EXPERIMENTAL

Urapidil Hydrochloride Injection

Intervention Type: COMBINATION_PRODUCT

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.

Guideline blood pressure control

Control blood pressure according to guidelines

Group Type: ACTIVE_COMPARATOR

Urapidil Hydrochloride Injection

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Diltiazem Hydrochloride for Injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Su Yingying

Role: primary

tangsuyingying@sina.com

15901361953

Other Identifiers

[2018]007

Identifier Type: -

Identifier Source: org_study_id