Intra-arterial tenecteplase during thrombectomy for acute stroke(BRETIS-TNK II):rationale and design  

作　　者：Zi-Ai Zhao Jing Qiu Wei Li Thanh Nguyen Shouchun Wang Huaizhang Shi Ming Wei Feng Wang Di Li Hui-Sheng Chen 

机构地区：[1]Department of Neurology,General Hospital of Northern Theater Command,Shenyang,Liaoning Province,China [2]Neurology,Radiology,Boston Medical Center,Boston,Massachusetts,USA [3]Department of Neurology,First Affiliated Hospital of Jilin University,Changchun,Jilin,China [4]Department of Neurosurgery,First Affiliated Hospital of Harbin Medical University,Harbin,Heilongjiang,China [5]Department of Neurosurgery,Tianjin Huanhu Hospital,Tianjin,Tianjin,China [6]Department of Interventional Therapy,First Affiliated Hospital of Dalian Medical University,Dalian,China [7]Neurological Intervention Department,Dalian Municipal Central Hospital,Dalian,Liaoning,China

出　　处：《Stroke & Vascular Neurology》2024年第1期59-65,共7页卒中与血管神经病学（英文）

基　　金：supported by grants from the Science and Technology Project Plan of Liao Ning Province(2022JH2/101500020);the Science and Technology Plan of Shen Yang(20-205-4-007).

摘　　要：Background Our recent pilot study suggests intra-arterial tenecteplase(TNK)during the first pass of endovascular treatment(EVT)seems safe,may increase first-pass reperfusion and good outcome in acute ischaemic stroke(AIS)patients with large-vessel occlusion(LVO).Aims To determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients presenting up to 24 hours from symptom onset.Sample size estimates A maximum of 380 patients are required to test the superiority hypothesis with 80%power according to a two-side 0.05 level of significance,stratified by age,gender,baseline systolic blood pressure,prestroke modified Rankin Scale(mRS),baseline National Institute of Health stroke scale,baseline ASPECTS,time from onset to groin puncture,intravenous thrombolysis before EVT,stroke territory and stroke aetiology.Design Intra-arterial TNK during thrombectomy for acute stroke(BRETIS-TNK II)study is a prospective,randomised,adaptive enrichment,open-label,blinded end point,multicentre study.Eligible AIS-LVO patients are randomly assigned into the experimental group and control group with a ratio of 1:1.The experimental group will be treated with intra-arterial infusion of TNK during EVT.The control group will be treated with standard EVT.Outcome The primary end point is a favourable outcome,defined as an mRS score of 0–2 at 90 days.The primary safety end point is symptomatic intracranial haemorrhage within 48 hours,which is defined as an increase in the National Institutes of Health Stroke Scale score of≥4 points as a result of the intracranial haemorrhage.Conclusions The results of BRETIS-TNK II will provide evidence for the efficacy and safety of intra-arterial TNK administration during EVT in AIS patients with LVO.

关 键 词：rational STRATIFIED TNK 

分 类 号：R743.3[医药卫生—神经病学与精神病学]