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

Caen University Hospital

Status: Unknown

Conditions: Stroke

Treatments: Biological: Thromboelastography

Study type: Observational

Funder types: Other

Identifiers

NCT02902393

15-202

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

64 participants in 1 patient group

Success of revascularisation

Treatment:

Biological: Thromboelastography