the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients
- Registration Number
- NCT06653946
- Lead Sponsor
- Kafrelsheikh University
- Brief Summary
The investigators evaluated the impact of AF on different subtypes of post-alteplase hemorrhagic transformation of brain infarction.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 716
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hemorragic transformation group Alteplase 262 acute ischemic stroke (AIS) patients who had a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase. non-hemorragic transformation group Alteplase 454 acute ischemic stroke (AIS) patients did not have a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase
- Primary Outcome Measures
Name Time Method the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group 48 days The investigators will evaluate the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group
- Secondary Outcome Measures
Name Time Method the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group 48 hours The investigators will evaluate the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group
the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group 48 hours The investigators will evaluate the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group
the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group 48 hours The investigators will evaluate the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group
Trial Locations
- Locations (1)
Kafr Elsheikh University Hospital
🇪🇬Kafr Ash Shaykh, Egypt