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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thrombolytic Therapy; Cerebrovascular Stroke; Mechanical Thrombectomy
• Intervention / Treatment: Other: thromboelastometry test

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Clémence h Tomadessos; Phone Number: +33231065386 +33231065386; Email: tomadesso-c@chu-caen.fr
• Study Contact Backup: Name: Richard Macrez; Phone Number: +33231065386 +33231065386; Email: macrez-r@chu-caen.fr

Study Locations

• France
  • Caen, France, 14000
    • University hospital of Caen, emergency department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Richard Macrez, Doctor, University hospital of Caen and faculty of medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): April 30, 2024
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (ACTUAL): May 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: thrombolysis; biomarker; thromboelastometry; ischemic stroke; endovascular thrombectomy; Prediction of revascularization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2021-A00171-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sample and clinical could be share with private researcher (STAGO)
• IPD Sharing Time Frame: At the end of the inclusion period
• IPD Sharing Access Criteria: The clinical and biological databases will be recorded by investigators and laboratory biologists respectively from the existing hospital information system. Anonymized data will be transferred via a secure server and encrypted messaging
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No