Evaluating factors predicting brain hemorrhage after stroke treatment with alteplase
Predictors of Post-alteplase Different Subtypes of Hemorrhagic Transformation of Brain Infarction in the Middle East
This study is trying to find out what factors might lead to bleeding in the brain after stroke patients receive a treatment called alteplase.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr Ash Shaykh) |
| Trial ID | NCT06337175 on ClinicalTrials.gov |
What this trial studies
This study investigates the predictors of post-alteplase hemorrhagic transformation in patients who have experienced an acute ischemic stroke. Conducted as a prospective cohort study, it screened 1450 patients and included 616 who met the criteria for thrombolysis with alteplase. The researchers assessed various characteristics, including door-to-needle time and stroke risk factors, to determine their relationship with different subtypes of hemorrhagic transformation. Follow-up brain imaging was performed to identify these subtypes in patients treated within four and a half hours of stroke onset.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 75 who present with their first-ever acute ischemic stroke and are eligible for thrombolysis.
Not a fit: Patients with contraindications to alteplase, recurrent ischemic strokes, or significant comorbidities such as major organ failure or active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at higher risk for hemorrhagic complications after alteplase treatment, leading to improved patient management and outcomes.
How similar studies have performed: Similar studies have explored predictors of hemorrhagic transformation, but this specific approach focusing on post-alteplase outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kafr Ash Shaykh
- Kafr Elsheikh University Hospital — Kafr Ash Shaykh, Egypt (Recruiting)
Study contacts
- Principal investigator: mohamed G. Zeinhom, MD — neurology department kafr el-sheikh university
- Study coordinator: mohamed G. Zeinhom, MD
- Email: mohamed_gomaa@med.kfs.edu.eg
- Phone: 2001009606828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.