Thromboelastometry and Ischemic Stroke (ThromboPredict)

Cerebrovascular Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04870684
• Other study ID #: 2021-A00171-40
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2021
• Source: University Hospital, Caen
• Contact: Clémence h Tomadessos
• Phone: +33231065386
• Email: tomadesso-c[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Stroke
• Mechanical Thrombectomy
• Stroke
• Thrombolytic Therapy

Intervention

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.

Locations

Country	Name	City	State
France	University hospital of Caen, emergency department	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Does clot firmness could predict the success of the revascularization	clot firmness (MCF in millimeter, mm)	One hour after the blood test
Primary	Prediction of the success of the revascularization procedure by thromboelastometry	clot lysis time (seconde).	One hour after the blood test
Secondary	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
Secondary	Thomboelastometry and prediction of thrombectomy efficacy	number of passes required for successful recanalization thrombolysis	immediatly after thrombectomy procedure
Secondary	Thomboelastometry and prediction of thrombectomy efficacy	puncture to recanalization (minute)	through study completion, an average of 3 years
Secondary	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
Secondary	Prediction of success of thrombolysis	presence or absence of a clot on MRI or angioscan	"Day 1", "Day 3" after thrombolysis
Secondary	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