Clinical trial NCT05282290: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Patients
Keywords: Ischemic stroke
Mechanical thrombectomy
Blood pressure
Symptomatic bleeding transformation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Modified Rankin Scale score
timeFrame: 90 days
Secondary outcomes:
measure: The incidence of symptomatic bleeding transformation
timeFrame: 48 hours
measure: National Institution of Health Stroke Scale scores
timeFrame: 48 hours
measure: Modified Rankin Scale score
timeFrame: 14 days
Other outcomes:
Locations:
city: XI'an
country: China
facility: XiJing hospital
state: Shaanxi
Study officials:
References:
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