Predictors of Post-alteplase Different Subtypes of Hemorrhagic Transformation of Brain Infarction in the Middle East
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- predictors of the hemorrhagic infarction type 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Hemorragic transformation group
One hundred fifty-two acute ischemic stroke (AIS) patients who had hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase.
干预措施: Alteplase (Drug)
non-hemorragic transformation group
Four hundred sixty-four acute ischemic stroke (AIS) patients did not have a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase.
干预措施: Alteplase (Drug)
结局指标
主要结局
predictors of the hemorrhagic infarction type 1
时间窗: 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.
次要结局
- predictors of the parenchymal hematoma type 1(48 hours)
- predictors of the parenchymal hematoma type 2(48 hours)
- predictors of the hemorrhagic infarction type 2(48 hours)
研究者
Mohamed G. zeinhom, MD
principal investigator
Kafrelsheikh University