Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients

Acute Stroke Clinical Trial

— THROMBONETS  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02907736
• Other study ID #: JDS_2015_45
• Status: Withdrawn
• First received: September 6, 2016
• Last updated: March 16, 2018
• Start date: November 12, 2015
• Est. completion date: July 1, 2017

Study information

• Verified date: March 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years old

• AIS secondary to a large vessel occlusion

• admitted for endovascular therapy.

Exclusion Criteria:

• Pregnant or breast feeding patient patient under legal protection

• Patient opposition to participate in this study

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thrombus origin	according to the etiology of the stroke (TOAST classification)	baseline
Primary	red cells counts	quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining :	baseline
Primary	white cells counts	quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining	baseline
Primary	platlet counts	quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining	baseline