An observational study in Cerebrovascular Stroke, Thrombolytic Therapy and Mechanical Thrombectomy, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-03.
Sponsored by University Hospital, Caen · Observational
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.
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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 1,692 observational studies indexed under Stroke.
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Patients >18 years with a diagnosis of ischemic stroke compatible and eligible for intravenous thrombolysis (IVT) with rt-PA and/or endovascular thrombectomy (EVT).
Inclusion Criteria:
Exclusion Criteria:
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.
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)
Time frame: One hour after the blood test
Does clot firmness could predict the success of the revascularization
clot firmness (MCF in millimeter, mm)
Time frame: One hour after the blood test
Prediction of the success of the revascularization procedure by thromboelastometry
clot lysis time (seconde).
Time frame: One hour after the blood test
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)
Time frame: during thrombectomy procedure
Thomboelastometry and prediction of thrombectomy efficacy
number of passes required for successful recanalization thrombolysis
Time frame: immediatly after thrombectomy procedure
Thomboelastometry and prediction of thrombectomy efficacy
puncture to recanalization (minute)
Time frame: 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)
Time frame: just at the end of thrombectomy procedure
Prediction of success of thrombolysis
presence or absence of a clot on MRI or angioscan
Time frame: "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.
Time frame: "D0", "Day 1", "Day 3" after revascularization
Plan to share: Yes — Sample and clinical could be share with private researcher (STAGO)
Supporting information: Study protocol, Sap, Csr, Analytic code
No publications or documents are linked to this record.
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University Hospital, Caen