NCT02948465

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

October 26, 2016

Last Update Submit

August 13, 2019

Conditions

Keywords

Neutrophil Extracellular Traps

Outcome Measures

Primary Outcomes (1)

  • Correlation coefficient between biochemical and histological composition of the thrombus and the sensibility in the in vitro fibrinolysis and the origin of the thrombus.

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cerebral infact after wide calibre arterial occlusion

You may qualify if:

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

You may not qualify if:

  • Patient benefiting from a legal protective measure
  • Pregnant or breast-feeding woman
  • Opposition of the patient to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Arturo CONSOLI, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR
  • Bertrand LAPERGUE, MD

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

July 22, 2016

Primary Completion

December 10, 2016

Study Completion

December 10, 2016

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations