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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Combination product: Urapidil Hydrochloride Injection

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital
      • Contact: Su Yingying; Phone Number: 15901361953; Email: tangsuyingying@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accurate blood pressure control; Implementing accurate blood pressure management under TCD monitoring	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.; Other Names: Diltiazem Hydrochloride for Injection
Active Comparator: Guideline blood pressure control; Control blood pressure according to guidelines	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.; Other Names: Diltiazem Hydrochloride for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: April 22, 2018
• First Submitted That Met QC Criteria: May 6, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Serotonin Agents; Serotonin Receptor Agonists; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Diltiazem; Urapidil
• Other Study ID Numbers: [2018]007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes