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Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia (THINK)

This study is currently recruiting participants.
Verified November 2017 by Hopital Foch
Sponsor:
ClinicalTrials.gov Identifier:
NCT02948465
First Posted: October 28, 2016
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  Purpose

Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular in proximal occlusion. Experimental studies suggest that neutrophils could play an important role in the thrombus development via the organization of a network (NET) within the thrombus. Targeting this network of NET could, in addition to the fibrinolysis, increase the rate of recanalisation and thus improve the neurological prognostic after a cerebral infarct.

The aim of the research is to Study of the biochemical and histological composition of the stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).


Condition
Cerebral Infarct

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Correlation coefficient between biochemical and histological composition of the thrombus and the sensibility in the in vitro fibrinolysis and the origin of the thrombus. [ Time Frame: 1 day ]

Estimated Enrollment: 120
Study Start Date: July 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cerebral infact after wide calibre arterial occlusion
Criteria

Inclusion Criteria:

  • Patient over 18
  • Having a cerebral infarct consecutive to a wide calibre arterial occlusion
  • taken care for mechanical thrombectomy

Exclusion Criteria:

  • Patient benefiting from a legal protective measure
  • Pregnant or breast-feeding woman
  • Opposition of the patient to participate in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948465


Contacts
Contact: Arturo CONSOLI, MD +33(0)146251955 a.consoli@hopital-foch.com
Contact: Bertrand LAPERGUE, MD

Locations
France
Hopital Foch Recruiting
Suresnes, France, 92150
Contact: Arturo Consoli, MD         
Principal Investigator: Arturo Consoli, MD         
Sub-Investigator: Bertrand Lapêrgue, MD         
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Arturo CONSOLI, MD Hopital Foch
Study Chair: Bertrand LAPERGUE, MD Hopital Foch
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02948465     History of Changes
Other Study ID Numbers: 2016/37
First Submitted: October 26, 2016
First Posted: October 28, 2016
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hopital Foch:
Neutrophil Extracellular Traps

Additional relevant MeSH terms:
Ischemia
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke