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

Not Applicable

Recruiting

• Conditions: Stroke Patients
• Interventions: Drug: Antihypertensive drugs (no restriction on the type of drugs)

• Registration Number: NCT05282290
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-16
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Study Start: 2022-09-22
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-26
• Last Update Posted: 2022-12-29
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group	Antihypertensive drugs (no restriction on the type of drugs)	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.
Experimental group	Antihypertensive drugs (no restriction on the type of drugs)	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.

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale score	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 .

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale score	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 .
The incidence of symptomatic bleeding transformation	48 hours	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	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

Trial Locations

Locations (1)

XiJing hospital; 🇨🇳 XI'an, Shaanxi, China