Thromboelastometry and Ischemic Stroke (ThromboPredict)

Caen University Hospital

Status: Unknown

Conditions: Cerebrovascular Stroke; Mechanical Thrombectomy; Thrombolytic Therapy

Treatments: Other: thromboelastometry test

Study type: Observational

Funder types: Other

Identifiers

NCT04870684

2021-A00171-40

Details and patient eligibility

About

In ischemic stroke, the recanalization rate after intravenous thrombolysis has been estimated to be less than 50% in patients with proximal intracranial artery occlusion; this rate is greater than 80% after endovascular thrombectomy. Thromboelastometry is a method of analysis of coagulation and fibrinolysis in whole blood. The main objective of this study is to evaluate whether the parameters obtained by thromboelastometry are predictive of revascularization at arteriography during mechanical thrombectomy, after treatment with rt-PA thrombolysis.

Full description

This is a single-center prospective observational study at the University Hospital of Caen. Any patient presenting a neurological deficit of sudden onset, compatible with a ischemic stroke diagnosed on brain imaging and eligible for thrombolysis by rtPA and/or a endovascular thrombectomy procedure will be included. Clot formation kinetics will be assessed by thromboelastometry (ROTEM® and/or QUANTRA®) to determine the predictive parameters of revascularization. The parameters of clot formation and lysis as well as revascularization according to thrombo-inflammation processes will be studied.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Diagnosis of ischemic stroke
• Decision of intravenous thrombolysis and/or endovascular thrombectomy by the neurologist and/or interventional neuroradiologist.
• Patient admitted to the emergency department during the hours and days when the hematology-biology laboratory is open (Monday to Friday from 8:30 a.m. to 6:30 p.m.)
• No opposition to the research from the patient or his relatives
• Inclusions according to the emergency procedure

Exclusion criteria

• Age < 18 ans
• Formal contraindication to thrombolysis and/or endovascular thrombectomy, disorders of hemostasis and anticoagulant treatment.

Trial design

200 participants in 1 patient group

sucess of revascularization

Description:

group of patients for whom after thrombolysis neurological improvement will be observed and recanalization on imaging will be seen.

Treatment:

Other: thromboelastometry test