NCT04870684

Thromboelastometry and Ischemic Stroke (ThromboPredict)

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Cerebrovascular Stroke
• Thrombolytic Therapy
• Mechanical Thrombectomy

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-04-30
• Completion: 2024-05-01
• First posted: 2021-05-03
• Last updated: 2021-05-03

Locations

1 site across 1 country: France