the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients

Официальное название

the Predictors of Different ECASS-based Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients Treated With Alteplase

Обзор

The investigators evaluated the impact of AF on different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

Подробное описание

Investigators conducted a prospective cohort study between July 2021 and July 2023. They screened 1550 patients who presented with AIS and received alteplase and included 716 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 454 patients who did not experience hemorrhagic infarction, while the second group comprised 262 patients who experienced hemorrhagic infarction.

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

Вмешательства

• Препарат Alteplase
  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
• Препарат Alteplase
  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

Первичные конечные точки

• the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group [Срок оценки: 48 days]

Вторичные конечные точки (3)

• the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group [Срок оценки: 48 hours]
• the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group [Срок оценки: 48 hours]
• the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group [Срок оценки: 48 hours]

Критерии участия

Критерии включения

• The investigators enrolled individuals of both genders, aged between 18 and 75,
• All patients had acute first-ever embolic ischemic stroke and were eligible for thrombolysis.
• All patients had Atrial fibrillation

Критерии исключения

• The investigators excluded patients who had alteplase contraindications
• The investigators excluded patients who did not receive the total dose of alteplase for any reason.
• The investigators excluded patients who had a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis)
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Kafr Elsheikh University Hospital — Kafr ash Shaykh

Публикации

• Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9. PMID 16731270
• Zeinhom MG, Aref HM, El-Khawas H, Roushdy TM, Shokri HM, Elbassiouny A. A pilot study of the ticagrelor role in ischemic stroke secondary prevention. Eur Neurol. 2022;85(1):50-55. doi: 10.1159/000518786. Epub 2021 Aug 30. PMID 34515113
• Bruno A, Levine SR, Frankel MR, Brott TG, Lin Y, Tilley BC, Lyden PD, Broderick JP, Kwiatkowski TG, Fineberg SE; NINDS rt-PA Stroke Study Group. Admission glucose level and clinical outcomes in the NINDS rt-PA Stroke Trial. Neurology. 2002 Sep 10;59(5):669-74. doi: 10.1212/wnl.59.5.669. PMID 12221155
• Ahmed SR, Zeinhom MG, Ebied AAMK, Kamel IFM, Almoataz MA, Daabis AMA, Akl AZO, Mahmoud ELA, Alkhalefeh AG, Ouf SG, Mosbah SAA, Sirag IMI, Abouelnaga M, Khalil MFE. A multi-center study on the predictors of different subtypes of hemorrhagic transformation of brain infarction after thrombolysis in atrial fibrillation patients presented with embolic stroke. Sci Rep. 2025 May 5;15(1):15655. doi: 10.10 PMID 40325067

Идентификаторы

NCT: NCT06653946 · 010120190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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