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Completed

NCT Number: NCT05258565

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

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.

Completed

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aswan University Hospital, Aswān, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV tPA (Activase)

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)

Other names: IV tissue plasminogen activator

Primary outcomes

  1. 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

  1. secondary outcome

    Time frame: 2 months

    NIHSS (pre-post drug administration and 2 month later a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items( Level of Consciousness ,Horizontal Eye Movement, Visual field test, Facial Palsy, Motor Arm, Motor Leg, Limb Ataxia ,Sensory, Language and Speech)

    , each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.Score 0 means No stroke symptoms. score 1-4 means Minor stroke .Score 5-15 means Moderate stroke. score 16-20 means Moderate to severe stroke. Score 21-42 means Severe stroke

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Aswan University Hospital

Registry information

Official study title

Tissue Plasminogen Activator (tPA) Therapy for Acute Ischemic Stroke in Covid -19 and Non Covid -19 Patients

Acronym: rTPA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2022
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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