Study Stopped
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Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients
THROMBONETS
1 other identifier
observational
N/A
1 country
1
Brief Summary
Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment and mortality worldwide despite the development of revascularization therapies (intravenous Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years, neutrophil extracellular traps (NETs) have been identified as major triggers and structural factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively correlated with the infarct size and negatively correlated with electrocardiogram (ST-segment) resolution. This later study revealed that in vitro addition of DNase I accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be promising targets for improved thrombolysis in AIS. The aim of this study is to assess the impact of NETs composition of thrombi retrieved during endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and AIS etiologies.
Trial Health
Trial Health Score
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Started Nov 2015
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 12, 2015
CompletedFirst Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedMarch 19, 2018
March 1, 2018
1.6 years
September 6, 2016
March 16, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
thrombus origin
according to the etiology of the stroke (TOAST classification)
baseline
red cells counts
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining :
baseline
white cells counts
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining
baseline
platlet counts
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining
baseline
Eligibility Criteria
Patients with acute stroke, admitted for endovascular therapy.
You may qualify if:
- age \> 18 years old
- AIS secondary to a large vessel occlusion
- admitted for endovascular therapy.
You may not qualify if:
- Pregnant or breast feeding patient patient under legal protection
- Patient opposition to participate in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019, France
Related Publications (1)
Ducroux C, Di Meglio L, Loyau S, Delbosc S, Boisseau W, Deschildre C, Ben Maacha M, Blanc R, Redjem H, Ciccio G, Smajda S, Fahed R, Michel JB, Piotin M, Salomon L, Mazighi M, Ho-Tin-Noe B, Desilles JP. Thrombus Neutrophil Extracellular Traps Content Impair tPA-Induced Thrombolysis in Acute Ischemic Stroke. Stroke. 2018 Mar;49(3):754-757. doi: 10.1161/STROKEAHA.117.019896. Epub 2018 Feb 8.
PMID: 29438080DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Philippe Désilles, MD
Fondation OPH A. de Rothschild
- STUDY CHAIR
Mikael Mazighi, MD, PhD
Fondation OPH A. de Rothschild
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2016
First Posted
September 20, 2016
Study Start
November 12, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
March 19, 2018
Record last verified: 2018-03