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

Primary Purpose

Acute Ischemic Stroke

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Urapidil Hydrochloride Injection
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuanwu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Accurate blood pressure control

Guideline blood pressure control

Arm Description

Implementing accurate blood pressure management under TCD monitoring

Control blood pressure according to guidelines

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

prognosis of nerve function
prognosis of nerve function use Modified Rankin Scale,0~3 is good prognosis and 4~6 is poor prognosis.

Full Information

First Posted
April 22, 2018
Last Updated
May 6, 2018
Sponsor
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT03529149
Brief Title
TCD Monitoring Technology Guides the Precise Control of Blood Pressure After EVT
Official Title
TCD Monitoring Technology Guides the Precise Control of Blood Pressure After EVT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 8, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Accurate blood pressure control
Arm Type
Experimental
Arm Description
Implementing accurate blood pressure management under TCD monitoring
Arm Title
Guideline blood pressure control
Arm Type
Active Comparator
Arm Description
Control blood pressure according to guidelines
Intervention Type
Combination Product
Intervention Name(s)
Urapidil Hydrochloride Injection
Other Intervention Name(s)
Diltiazem Hydrochloride for Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
early neurological deterioration
Description
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
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
prognosis of nerve function
Description
prognosis of nerve function use Modified Rankin Scale,0~3 is good prognosis and 4~6 is poor prognosis.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Xuanwu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Yingying
Phone
15901361953
Email
tangsuyingying@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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