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

Stroke Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282290
• Other study ID #: KY20212150
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: December 2022
• Source: Xijing Hospital
• Contact: li li, Dr.
• Phone: 13709115155
• Email: Lili[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Reperfusion Injury
• Stroke
• Stroke Patients

Intervention

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.

Locations

Country	Name	City	State
China	XiJing hospital	XI'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (18)

Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama a Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van — View Citation

Bracard S, Ducrocq X, Mas JL, Soudant M, Oppenheim C, Moulin T, Guillemin F; THRACE investigators. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomised controlled trial. Lancet Neurol. 2016 Oct;15( — View Citation

Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGu — View Citation

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Hao Y, Yang D, Wang H, Zi W, Zhang M, Geng Y, Zhou Z, Wang W, Xu H, Tian X, Lv P, Liu Y, Xiong Y, Liu X, Xu G; ACTUAL Investigators (Endovascular Treatment for Acute Anterior Circulation Ischemic Stroke Registry). Predictors for Symptomatic Intracranial H — View Citation

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Xu AD, Wang YJ, Wang DZ; Chinese Stroke Therapy Expert Panel for Intravenous Recombinant Tissue Plasminogen Activator. Consensus statement on the use of intravenous recombinant tissue plasminogen activator to treat acute ischemic stroke by the Chinese Str — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	90 days
Secondary	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.	48 hours
Secondary	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	48 hours
Secondary	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 .	14 days