Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke

NCT ID: NCT02902393

Last Updated: 2016-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-09-30

Brief Summary

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Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy.

The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Success of revascularisation

Thromboelastography

Intervention Type BIOLOGICAL

Interventions

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Thromboelastography

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patient (\> 18 years) with a neurological deficit compatible with a neurovascular pathology eligible for fibrinolysis rtPA and having a proximal occlusion of the middle cerebral artery (segment M1 / M2) or basilar trunk objectified brain imaging (MRI angiography or angio CT).

Exclusion Criteria

* Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard MACREZ, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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University Hospital

Caen, Calvados, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Yohann REPESSE, MD PhD

Role: CONTACT

+330231063315

Facility Contacts

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Christophe Kassel

Role: primary

0231063106 ext. +33

Other Identifiers

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15-202

Identifier Type: -

Identifier Source: org_study_id

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