TPA in Acute Stroke With COVID Verus Non-COVID-19 Patients
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): IV tPA (Activase)
Intervention type(s): Drug
Intervention description(s): Any patients eligible came with acute ischemic stroke with or without COVID-19 infection within the time window for thrombolytic therapy (within 4 hours of onset)
Other intervention name(s): IV tissue plasminogen activator
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment