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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05282290
Enrollment
120
Registered
2022-03-16
Start date
2022-09-22
Completion date
2024-05-01
Last updated
2022-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Patients

Keywords

Ischemic stroke, Mechanical thrombectomy, Blood pressure, Symptomatic bleeding transformation

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.

Interventions

DRUGAntihypertensive 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.

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale score90 daysGood 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

MeasureTime frameDescription
The incidence of symptomatic bleeding transformation48 hoursThe secondary outcome was the incidence of symptomatic bleeding transformation due to reperfusion injury within 48 hours after surgery.
National Institution of Health Stroke Scale scores48 hoursNIHSS 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 score14 daysThe 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 .

Countries

China

Contacts

Primary Contactli li, Dr.
Lili@fmmu.edu.cn13709115155
Backup Contacthanghang zhao, Master
ljhh_2021@163.com15832791770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026