Tissue Plasminogen Activator (tPA) Therapy for Acute Ischemic Stroke in Covid -19 and Non Covid -19 Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- primary out come
研究概览
简要总结
The investigator will recruit consecutively all patients coming with acute ischemic stroke either with or without COVID -19 infection and suitable for IV injection with Tissue plasminogen activators according to guideline and inclusion criteria of tPA.
Aswan University Hospital.
详细描述
Acute ischemic stroke (AIS) is a time sensitive medical emergency and a leading cause of morbidity and mortality worldwide. Intravenous (IV) recombinant tissue plasminogen activator (IV alteplase) is currently the only proven effective medication for the treatment of AIS with promising adjuvant medications currently under investigation.(Gottula et al, 2021).
Intravenous tissue plasminogen activator (tPA) is used to treat acute stroke because of its thrombolytic activity and its ability to restore circulation to the brain. (Wang, et. al, 1998). However tPA administration, especially delayed administration is associated with increased intracranial hemorrhage, hemorrhagic transformation and mortality. (Jong, 2019) Acute cerebrovascular disease, particularly ischemic stroke, has emerged as a serious complication of infection by the severe acute respiratory syndrome coronavirus that caused by the Coronavirus disease-2019 (COVID-19). Such specificities include a propensity towards large vessel occlusion, multi-territory stroke, and involvement of otherwise uncommonly affected vessels. The pathogenesis and optimal management of ischemic stroke associated with COVID-19 still remain uncertain, but emerging evidence suggest that cytokine storm-triggered coagulopathy and endotheliopathy represent possible targetable mechanisms. (Vogrig, et. al, 2021).
Anew study was done in United States in 2020, included 13 patients presented with acute ischemic stroke and systemic symptoms consistent with covid-19 were treated with IV tPA. 61.5% of patients improved at follow up, Neither of them complicated with systemic or symptomatic intracranial hemorrhages.(Carneiro, et. al, 2020). IV tPA may be safe and efficacious in COVID -19 but larger studies are needed to validate these results (Carneiro, et. al, 2020).
The purpose of this study is to compare between the safety and efficacy of tPA management of ischemic stroke in Covid-19 and non covid-19 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically diagnosed as acute ischemic stroke NIHSS<25
- •Symptoms onset less than 4.5 hours (3hours in diabetic or having a previous stroke) before beginning treatment.
排除标准
- •History of:
- •A previous ischemic stroke or severe head trauma in previous 3 months.
- •Previous intracranial hemorrhage .
- •Intracranial neoplasm or gastrointestinal malignancy.
- •Gastrointestinal hemorrhage in previous 3weeks.
- •Intracranial or intra spinal surgery in previous 3months
- •Clinically:
- •Symptoms suggestive of subarachnoid hemorrhage.
- •Persistent blood pressure elevation, systolic > 185 or diastolic >110 mmHg.
- •Active internal bleeding.
- •Presentations consistent with infective endocarditis.
- •Stroke known or suspected to be associated with aortic arch dissection.
- •Acute bleeding diathesis, including but not limited to conditions defined under hematologic.
- •Hematologic:
- •Platelet count <100.000 \ mm3
- •Current anticoagulant use with INR>1.7 or PT>15sec or PTT> 40sec.
- •Therapeutic doses of low molecular weight received in 24 hours (not include the prophylactic doses).
- •Evidence of hemorrhage.
- •Extensive regions of obvious hypo density
研究组 & 干预措施
acute ischemic stroke without covid -19 infection
Administration of IV tPA: the dose of activase is ,9 mg /kg (not exceeding 90 mg total treatment dose) Infused over 90 minutes.
干预措施: IV tPA (Activase) (Drug)
acute ischemic stroke associated with covid -19 infection
Administration of IV tPA: the dose of activase is, 9 mg /kg (not exceeding 90 mg total treatment dose) Infused over 90 minutes.
干预措施: IV tPA (Activase) (Drug)
结局指标
主要结局
primary out come
时间窗: 2 months
Barthel Index scale BIS (pre-post drug administration and 2 month later)The Barthel includes 10 personal activities: feeding, personal toileting, bathing, dressing and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface (or propelling a wheelchair if unable to walk) and ascending and descending stairs. The original Index is a three-item ordinal rating scale completed by a therapist or other observer in 2-5 minutes. Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.
次要结局
- secondary outcome(2 months)
研究者
Eman M. Khedr
clinical professor
Assiut University