Thromboelastometry and Ischemic Stroke (ThromboPredict)

NCT04870684 | Unknown

• 1 other identifier: 2021-A00171-40
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Stroke; Thrombolytic Therapy; Mechanical Thrombectomy

Keywords

thromboelastometry; ischemic stroke; biomarker; thrombolysis; endovascular thrombectomy; Prediction of revascularization

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Thomboelastometry and prediction of thrombolysis + thrombectomy efficacy

  during thrombectomy procedure

• Thomboelastometry and prediction of thrombectomy efficacy

  immediatly after thrombectomy procedure

• Thomboelastometry and prediction of thrombectomy efficacy

  through study completion, an average of 3 years

• Thomboelastometry and prediction of success of recanalization by thrombectomy alone

  just at the end of thrombectomy procedure

• Prediction of success of thrombolysis

  "Day 1", "Day 3" after thrombolysis

Study Arms (1)

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

Interventions

thromboelastometry test OTHER

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.

sucess of revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 ans
• Formal contraindication to thrombolysis and/or endovascular thrombectomy, disorders of hemostasis and anticoagulant treatment.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University hospital of Caen, emergency department

Caen, 14000, France

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard Macrez, Doctor

  University hospital of Caen and faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clémence h Tomadessos

CONTACT

+33231065386; tomadesso-c@chu-caen.fr

Richard Macrez

CONTACT

+33231065386; macrez-r@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: May 3, 2021
• Study Start: May 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: May 1, 2024
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: At the end of the inclusion period
• 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

Locations

FR (1)