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Completed

NCT Number: NCT06337175

Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction

The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

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Key information

Conditions

Ischemic Stroke Alteplase Adverse Reaction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33155, Egypt

About this study

Investigators conducted a prospective cohort study between June 2021 and October 2023. They screened 1450 patients who presented with AIS and received alteplase and included 616 AIS patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination, and specific brain imaging results and treated with alteplase within four and half hours of stroke onset.

The investigators assessed the patients' follow-up brain imaging to detect the subtypes of hemorrhagic transformation after receiving alteplase.

The study consisted of two distinct groups. The first group consisted of 464 patients who did not experience hemorrhagic infarction, while the second group comprised 152 patients who experienced hemorrhagic infarction.

The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The investigators enrolled individuals of both genders, aged between 18 and 75, who presented with acute first-ever ischemic stroke and were eligible for thrombolysis.

Exclusion criteria

  • The investigators excluded patients who had not been followed up on for 90 days after enrollment,
  • Those with alteplase contraindications or did not receive the total dose of alteplase due to any reason were excluded
  • The investigators excluded patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit).
  • The investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or MRI brain findings.
  • The investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks.
  • The investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest

Treatment and study plan

alteplase

Drug

Following the guidelines set by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit.

Primary outcomes

  1. predictors of the hemorrhagic infarction type 1

    Time frame: 48 hours

    The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict hemorrhagic infarction type 1 after 24-36 hours of receiving alteplase after acute ischemic stroke.

Secondary outcomes

  1. predictors of the hemorrhagic infarction type 2

    Time frame: 48 hours

    The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict hemorrhagic infarction type 1 after 24-36 hours of receiving alteplase after acute ischemic stroke.

  2. predictors of the parenchymal hematoma type 1

    Time frame: 48 hours

    The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict parenchymal hematoma type 1 after 24-36 hours of receiving alteplase after acute ischemic stroke.

  3. predictors of the parenchymal hematoma type 2

    Time frame: 48 hours

    The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict parenchymal hematoma type 2 after 24-36 hours of receiving alteplase after acute ischemic stroke.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Predictors of Post-alteplase Different Subtypes of Hemorrhagic Transformation of Brain Infarction in the Middle East

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 29, 2024
Registry last updated
Sep 5, 2025

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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