Thromboelastometry and Ischemic Stroke (ThromboPredict)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Prediction of the success of the revascularization procedure by thromboelastometry [One hour after the blood test]
All the parameters of clot formation and lysis will be studied, in particular the area under the curve (AUC)
- Does clot firmness could predict the success of the revascularization [One hour after the blood test]
clot firmness (MCF in millimeter, mm)
- Prediction of the success of the revascularization procedure by thromboelastometry [One hour after the blood test]
clot lysis time (seconde).
Secondary Outcome Measures
- Thomboelastometry and prediction of thrombolysis + thrombectomy efficacy [during thrombectomy procedure]
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)
- Thomboelastometry and prediction of thrombectomy efficacy [immediatly after thrombectomy procedure]
number of passes required for successful recanalization thrombolysis
- Thomboelastometry and prediction of thrombectomy efficacy [through study completion, an average of 3 years]
puncture to recanalization (minute)
- Thomboelastometry and prediction of success of recanalization by thrombectomy alone [just at the end of thrombectomy procedure]
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)
- Prediction of success of thrombolysis ["Day 1", "Day 3" after thrombolysis]
presence or absence of a clot on MRI or angioscan
- Thomboelastometry and prediction of neurological outcome ["D0", "Day 1", "Day 3" after revascularization]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University hospital of Caen, emergency department | Caen | France | 14000 |
Sponsors and Collaborators
- University Hospital, Caen
Investigators
- Principal Investigator: Richard Macrez, Doctor, University hospital of Caen and faculty of medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-A00171-40