Clinical trial NCT04870684: Thromboelastometry and Ischemic Stroke (ThromboPredict)
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Stroke
Thrombolytic Therapy
Mechanical Thrombectomy
Keywords: thromboelastometry
ischemic stroke
biomarker
thrombolysis
endovascular thrombectomy
Prediction of revascularization
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>18 years with a diagnosis of ischemic stroke compatible and eligible for intravenous thrombolysis (IVT) with rt-PA and/or endovascular thrombectomy (EVT).

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prediction of the success of the revascularization procedure by thromboelastometry
timeFrame: One hour after the blood test
measure: Does clot firmness could predict the success of the revascularization
timeFrame: One hour after the blood test
measure: Prediction of the success of the revascularization procedure by thromboelastometry
timeFrame: One hour after the blood test
Secondary outcomes:
measure: Thomboelastometry and prediction of thrombolysis + thrombectomy efficacy
timeFrame: during thrombectomy procedure
measure: Thomboelastometry and prediction of thrombectomy efficacy
timeFrame: immediatly after thrombectomy procedure
measure: Thomboelastometry and prediction of thrombectomy efficacy
timeFrame: through study completion, an average of 3 years
measure: Thomboelastometry and prediction of success of recanalization by thrombectomy alone
timeFrame: just at the end of thrombectomy procedure
measure: Prediction of success of thrombolysis
timeFrame: "Day 1", "Day 3" after thrombolysis
measure: Thomboelastometry and prediction of neurological outcome
timeFrame: "D0", "Day 1", "Day 3" after revascularization
Other outcomes:
Locations:
city: Caen
country: France
facility: University hospital of Caen, emergency department
Study officials:
affiliation: University hospital of Caen and faculty of medicine
name: Richard Macrez, Doctor
role: PRINCIPAL_INVESTIGATOR
References: