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

December 26, 2022 updated by: Xijing Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • XI'an, Shaanxi, China, 710000
        • Recruiting
        • Xijing Hospital
        • Contact:
          • HangHang Zhao, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
  1. Lower systolic blood pressure to 90-110 mm Hg.
  2. Blood pressure not lower than 90/60 mm Hg
  3. Hypotensive maintenance treatment for 48 hours.
Drug: Antihypertensive drugs (no restriction on the type of drugs)

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.
Active Comparator: The control group
  1. Subjects with basic blood pressure(BBP) > 140/90 mm Hg should have BBP lowered to about 140/90 mm Hg.
  2. Subjects whose BBP was less than 140/90mm Hg were kept BBP.
Drug: Antihypertensive drugs (no restriction on the type of drugs)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale score
Time Frame: 90 days

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 .
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of symptomatic bleeding transformation
Time Frame: 48 hours
The secondary outcome was the incidence of symptomatic bleeding transformation due to reperfusion injury within 48 hours after surgery.
48 hours
National Institution of Health Stroke Scale scores
Time Frame: 48 hours

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
48 hours
Modified Rankin Scale score
Time Frame: 14 days
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 .
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20212150

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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