Thromboelastometry and Ischemic Stroke (ThromboPredict)

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebrovascular Stroke Thrombolytic Therapy Mechanical Thrombectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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sucess of revascularization

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

thromboelastometry test

Intervention Type OTHER

This study does not modify the usual care of the patient. Only 5 citrated tubes (maximum 15 mL of blood) are collected in addition to the initial emergency department sample (routine care). The patient's care follows the classic thrombolysis alert pathway. There is no additional complementary examination or additional neurological evaluation. Clot formation kinetics will be evaluated by thromboelastometry to determine the predictive parameters of revascularization. Clot formation and lysis parameters as well as revascularization according to thrombo-inflammation processes will be studied.

Interventions

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thromboelastometry test

This study does not modify the usual care of the patient. Only 5 citrated tubes (maximum 15 mL of blood) are collected in addition to the initial emergency department sample (routine care). The patient's care follows the classic thrombolysis alert pathway. There is no additional complementary examination or additional neurological evaluation. Clot formation kinetics will be evaluated by thromboelastometry to determine the predictive parameters of revascularization. Clot formation and lysis parameters as well as revascularization according to thrombo-inflammation processes will be studied.

Intervention Type OTHER

Eligibility Criteria

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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