Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339411
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-25
Brief Title:
Exploring Cerebrolysin in Late Thrombectomy for Stroke Blood-brain Barrier Biomarkers and Imaging Insights
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Examining the Efficacy of Cerebrolysin-Augmented Extended Time Window Thrombectomy in Acute Ischemic Stroke An In-depth Study of Blood-brain Barrier Biomarkers and Imaging Indicators
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Stroke is a leading cause of mortality and disability globally with acute ischemic strokesAIS due to Large Vessel Occlusion LVO presenting significant treatment challenges Mechanical thrombectomy MT has emerged as an effective intervention for AIS within an 8-hour window from symptom onset However the potential to extend this window up to 24 hours for select patients could revolutionize outcomes for those arriving late at comprehensive stroke centers This study investigates the efficacy and safety of Cerebrolysin as an adjunct therapy to MT in extended time window and improving patient recovery
Methods
We conducted a multi-center prospective randomized study within the Chang Gung Memorial Hospital system in Taiwan targeting 100 AIS patients eligible for MT beyond the traditional 8-hour window Participants were randomized to receive either standard care or Cerebrolysin post-MT initiated within 24 hours of stroke onset and continued for 14 days The study assessed neurological neuropsychological and biomarker outcomes at multiple time points post-stroke to evaluate the effects of Cerebrolysin on recovery
Results
The primary outcome will measure the proportion of patients achieving favorable functional outcomes modified Rankin Scale 0-2 at 90 days Secondary outcomes include the impact of Cerebrolysin on secondary hemorrhagic transformation brain edema mortality rates and quality of life The study aims to provide comprehensive data on the benefits of adding Cerebrolysin to the standard post-MT care focusing on its potential to protect against reperfusion injuries and maintain blood-brain barrier integrity
Conclusion
By evaluating the role of Cerebrolysin in conjunction with MT this study aims to extend the therapeutic window for AIS treatment offering hope for improved outcomes for patients who would otherwise be ineligible for current reperfusion therapies The findings may pave the way for new guidelines in stroke management emphasizing the importance of integrated care approaches in enhancing patient recovery
Stroke is a leading cause of mortality and disability globally with acute ischemic strokesAIS due to Large Vessel Occlusion LVO presenting significant treatment challenges Mechanical thrombectomy MT has emerged as an effective intervention for AIS within an 8-hour window from symptom onset However the potential to extend this window up to 24 hours for select patients could revolutionize outcomes for those arriving late at comprehensive stroke centers This study investigates the efficacy and safety of Cerebrolysin as an adjunct therapy to MT in extended time window and improving patient recovery
Methods
We conducted a multi-center prospective randomized study within the Chang Gung Memorial Hospital system in Taiwan targeting 100 AIS patients eligible for MT beyond the traditional 8-hour window Participants were randomized to receive either standard care or Cerebrolysin post-MT initiated within 24 hours of stroke onset and continued for 14 days The study assessed neurological neuropsychological and biomarker outcomes at multiple time points post-stroke to evaluate the effects of Cerebrolysin on recovery
Results
The primary outcome will measure the proportion of patients achieving favorable functional outcomes modified Rankin Scale 0-2 at 90 days Secondary outcomes include the impact of Cerebrolysin on secondary hemorrhagic transformation brain edema mortality rates and quality of life The study aims to provide comprehensive data on the benefits of adding Cerebrolysin to the standard post-MT care focusing on its potential to protect against reperfusion injuries and maintain blood-brain barrier integrity
Conclusion
By evaluating the role of Cerebrolysin in conjunction with MT this study aims to extend the therapeutic window for AIS treatment offering hope for improved outcomes for patients who would otherwise be ineligible for current reperfusion therapies The findings may pave the way for new guidelines in stroke management emphasizing the importance of integrated care approaches in enhancing patient recovery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None