TPA in Acute Stroke With COVID Verus Non-COVID-19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-09-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

IV tPA (Activase)

Intervention Type DRUG

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)

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.

Group Type ACTIVE_COMPARATOR

IV tPA (Activase)

Intervention Type DRUG

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)

Interventions

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IV tPA (Activase)

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)

Intervention Type DRUG

Other Intervention Names

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IV tissue plasminogen activator

Eligibility Criteria

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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.
* 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).

Head CT:

* Evidence of hemorrhage.
* Extensive regions of obvious hypo density

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes