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

NCT03529149 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: [2018]007
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• prognosis of nerve function

  3 months

Study Arms (2)

Accurate blood pressure control

EXPERIMENTAL

Implementing accurate blood pressure management under TCD monitoring

Combination Product: Urapidil Hydrochloride Injection

Guideline blood pressure control

ACTIVE COMPARATOR

Control blood pressure according to guidelines

Combination Product: Urapidil Hydrochloride Injection

Interventions

Urapidil Hydrochloride Injection 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.

Also known as: Diltiazem Hydrochloride for Injection

Accurate blood pressure control; Guideline blood pressure control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

urapidil; Diltiazem; Injections

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: May 18, 2018
• Study Start: April 8, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)