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Prevention and Treatment of Reperfusion Injury After Mechanical Thrombectomy in Acute Ischemic Stroke

Primary Purpose

Stroke Patients

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Antihypertensive drugs (no restriction on the type of drugs)
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke Patients focused on measuring Ischemic stroke, Mechanical thrombectomy, Blood pressure, Symptomatic bleeding transformation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with acute cerebral infarction with large vessel occlusion within 24 hours of onset .(internal carotid artery, M1 or M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery).
  • 18 years≤age≤85 years.
  • CT ruled out cerebral hemorrhage and subarachnoid hemorrhage.
  • Informed consent signed by patient or legal representative.
  • Successful vascular recanalization (defined as modified thrombolysis in cerebral infarction (mTICI)≥2b/3 for cerebral infarction with anterior bleeding).
  • Degree of disease: 6 points≤NIHSS ≤19 points.

Exclusion Criteria:

  • Preoperative or immediate postoperative CT showed active bleeding or was known to have significant bleeding tendency [International Normalized Ratio(INR)>3.0,Platelet count <30×10 9/L.
  • Severe heart, liver and kidney insufficiency.
  • Blood glucose <2.7mmol/L or >22.2mmol/L.
  • Severe hyperemia beyond medication control (>180/105mm Hg).
  • Patients with Alberta early stroke grading CT scores (ASPECT)<6.
  • Patients with a life expectancy of less than 90 days.
  • Blood pressure is below 90/60 mm Hg.
  • mRS≥3 points .
  • pregnant women.

Sites / Locations

  • XiJing hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

The control group

Arm Description

Lower systolic blood pressure to 90-110 mm Hg. Blood pressure not lower than 90/60 mm Hg Hypotensive maintenance treatment for 48 hours.

Subjects with basic blood pressure(BBP) > 140/90 mm Hg should have BBP lowered to about 140/90 mm Hg. Subjects whose BBP was less than 140/90mm Hg were kept BBP.

Outcomes

Primary Outcome Measures

Modified Rankin Scale score
Good prognosis rate (mRS ≤ 2 points) at 90 days after surgery in the test and control groups. Modified Rankin Scale scores range from 0 to 6, with a lower score indicating a better prognosis .

Secondary Outcome Measures

The incidence of symptomatic bleeding transformation
The secondary outcome was the incidence of symptomatic bleeding transformation due to reperfusion injury within 48 hours after surgery.
National Institution of Health Stroke Scale scores
NIHSS scores at 48 hours postoperatively in the test group and the control group. NIHSS scores range from 0-42, the higher the score the more severe the patient's clinical symptoms
Modified Rankin Scale score
The mRS scores at 14 days after surgery in the test and control groups. Modified Rankin Scale scores range from 0 to 6, with a lower score indicating a better prognosis .

Full Information

First Posted
January 16, 2022
Last Updated
December 26, 2022
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05282290
Brief Title
Prevention and Treatment of Reperfusion Injury After Mechanical Thrombectomy in Acute Ischemic Stroke
Official Title
Prevention and Treatment of Reperfusion Injury After Mechanical Thrombectomy in Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Ischemic stroke accounts for 80% of all strokes and there is a lack of effective treatment options.Mechanical thrombectomy can significantly improve the vascular recanalization rate and reduce the disability rate of stroke, but the problem of reperfusion injury caused by vascular recanalization is more prominent than before. The most common manifestation of reperfusion injury is postoperative hemorrhage transformation in the infarct area, which is caused by the inability of blood vessels to tolerate normal perfusion pressure after endothelial cell injury.Therefore, in addition to using necessary strategies to reduce the risk of bleeding before and during surgery, maintaining an appropriate and individualized perfusion pressure after surgery is also an important strategy to prevent and treat postoperative bleeding. Lead a multicenter, randomized, controlled study looking at Individuation lowers blood pressure.( Drop systolic blood pressure to 90-110mmHg,Blood pressure not lower than 90/60 mm Hg,The reduced blood pressure was maintained for 48 hours). Influence of the incidence of hemorrhage transformation caused by reperfusion injury after mechanical thrombectomy and prognosis (modified Rankin Scale (mRS) score and proportion of patients with mRS≤2) at 48hours, 14 and 90 days after surgery.Thus, provide clinical evidence for blood pressure management strategy after mechanical thrombectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients
Keywords
Ischemic stroke, Mechanical thrombectomy, Blood pressure, Symptomatic bleeding transformation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Lower systolic blood pressure to 90-110 mm Hg. Blood pressure not lower than 90/60 mm Hg Hypotensive maintenance treatment for 48 hours.
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
Subjects with basic blood pressure(BBP) > 140/90 mm Hg should have BBP lowered to about 140/90 mm Hg. Subjects whose BBP was less than 140/90mm Hg were kept BBP.
Intervention Type
Drug
Intervention Name(s)
Antihypertensive drugs (no restriction on the type of drugs)
Intervention Description
The division of care unit doctors and nurses is clear, the former is responsible for giving medical advice, the latter is responsible for carrying it out. The experimental group and the control group were given intravenous antihypertensive drugs (no restriction on the type of drugs), and their blood pressure reached the standard within 2 hours after vascular opening.
Primary Outcome Measure Information:
Title
Modified Rankin Scale score
Description
Good prognosis rate (mRS ≤ 2 points) at 90 days after surgery in the test and control groups. Modified Rankin Scale scores range from 0 to 6, with a lower score indicating a better prognosis .
Time Frame
90 days
Secondary Outcome Measure Information:
Title
The incidence of symptomatic bleeding transformation
Description
The secondary outcome was the incidence of symptomatic bleeding transformation due to reperfusion injury within 48 hours after surgery.
Time Frame
48 hours
Title
National Institution of Health Stroke Scale scores
Description
NIHSS scores at 48 hours postoperatively in the test group and the control group. NIHSS scores range from 0-42, the higher the score the more severe the patient's clinical symptoms
Time Frame
48 hours
Title
Modified Rankin Scale score
Description
The mRS scores at 14 days after surgery in the test and control groups. Modified Rankin Scale scores range from 0 to 6, with a lower score indicating a better prognosis .
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute cerebral infarction with large vessel occlusion within 24 hours of onset .(internal carotid artery, M1 or M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery). 18 years≤age≤85 years. CT ruled out cerebral hemorrhage and subarachnoid hemorrhage. Informed consent signed by patient or legal representative. Successful vascular recanalization (defined as modified thrombolysis in cerebral infarction (mTICI)≥2b/3 for cerebral infarction with anterior bleeding). Degree of disease: 6 points≤NIHSS ≤19 points. Exclusion Criteria: Preoperative or immediate postoperative CT showed active bleeding or was known to have significant bleeding tendency [International Normalized Ratio(INR)>3.0,Platelet count <30×10 9/L. Severe heart, liver and kidney insufficiency. Blood glucose <2.7mmol/L or >22.2mmol/L. Severe hyperemia beyond medication control (>180/105mm Hg). Patients with Alberta early stroke grading CT scores (ASPECT)<6. Patients with a life expectancy of less than 90 days. Blood pressure is below 90/60 mm Hg. mRS≥3 points . pregnant women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
li li, Dr.
Phone
13709115155
Email
Lili@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
hanghang zhao, Master
Phone
15832791770
Email
ljhh_2021@163.com
Facility Information:
Facility Name
XiJing hospital
City
XI'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HangHang Zhao, Bachelor

12. IPD Sharing Statement

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Prevention and Treatment of Reperfusion Injury After Mechanical Thrombectomy in Acute Ischemic Stroke

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