Tissue Plasminogen Activator (tPA) Therapy for Acute Ischemic Stroke in Covid -19 and Non Covid -19 Patients
Overview
- Phase
- Phase 1
- Intervention
- IV tPA (Activase)
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Assiut University
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- primary out come
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eman M. Khedr
clinical professor
Assiut University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: IV tPA (Activase)
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.
Intervention: IV tPA (Activase)
Outcomes
Primary Outcomes
primary out come
Time Frame: 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.
Secondary Outcomes
- secondary outcome(2 months)