Thromboelastometry and Ischemic Stroke (ThromboPredict)

Study Overview
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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.

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.

Official Title
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Interest of Thromboelastometry as a Biomarker of Post-thrombolysis or Post-thrombectemia Revascularization Success in Ischemic Stroke: a Prospective, Single-center, Observational Study in an Emergency Department

Conditions
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Cerebrovascular Stroke, Thrombolytic Therapy, Mechanical Thrombectomy

Intervention / Treatment
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* Other: thromboelastometry test


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sucess of revascularization<br>group of patients for whom after thrombolysis neurological improvement will be observed and recanalization on imaging will be seen. | Other: thromboelastometry test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of the success of the revascularization procedure by thromboelastometry | All the parameters of clot formation and lysis will be studied, in particular the area under the curve (AUC) | One hour after the blood test | 
| Does clot firmness could predict the success of the revascularization | clot firmness (MCF in millimeter, mm) | One hour after the blood test | 
| Prediction of the success of the revascularization procedure by thromboelastometry | clot lysis time (seconde). | One hour after the blood test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thomboelastometry and prediction of thrombolysis + thrombectomy efficacy | effectiveness of thrombectomy will be assessed per-arteriogram by the TICI score (Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion) | during thrombectomy procedure | 
| Thomboelastometry and prediction of thrombectomy efficacy | number of passes required for successful recanalization thrombolysis | immediatly after thrombectomy procedure | 
| Thomboelastometry and prediction of thrombectomy efficacy | puncture to recanalization (minute) | through study completion, an average of 3 years | 
| Thomboelastometry and prediction of success of recanalization by thrombectomy alone | Effectiveness of thrombectomy will be assessed by the TICI score ((Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion) | just at the end of thrombectomy procedure | 
| Prediction of success of thrombolysis | presence or absence of a clot on MRI or angioscan | Day 1, Day 3 after thrombolysis | 
| Thomboelastometry and prediction of neurological outcome | The use of the NIHSS score will allow the neurological evaluation of the patient (at admission and 24h/72h after the recanalization attempt). Neurological outcome, as assessed by the NIHSS score, is considered favorable if the NIHSS score at 24h/72h post-recanalization is equal to 0 or 1 or if there is an improvement in the NIHSS score of at least four points between the admission score and the score at 24h/72h post-recanalization. | D0, Day 1, Day 3 after revascularization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thromboelastometry, ischemic stroke, biomarker, thrombolysis, endovascular thrombectomy, Prediction of revascularization