Cerebrovascular StrokeNCT04870684
Thromboelastometry and Ischemic Stroke (ThromboPredict)
An observational study of Cerebrovascular Stroke and Thrombolytic Therapy, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Stroke, Thrombolytic Therapy, Mechanical Thrombectomy
- What is being tested?
- thromboelastometry test
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Age < 18 ans
- Formal contraindication to thrombolysis and/or endovascular thrombectomy, disorders of hemostasis and anticoagulant treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- thromboelastometry test
- Keywords
- thromboelastometry, ischemic stroke, biomarker, thrombolysis, endovascular thrombectomy, Prediction of revascularization
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thromboelastometry testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| sucess of revascularization | group of patients for whom after thrombolysis neurological improvement will be observed and recanalization on imaging will be seen. Receives: Other: thromboelastometry test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One hour after the blood test
Does clot firmness could predict the success of the revascularization
clot firmness (MCF in millimeter, mm)
Measured: One hour after the blood test
Prediction of the success of the revascularization procedure by thromboelastometry
clot lysis time (seconde).
Measured: One hour after the blood test
Secondary outcomes (6)
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)
Measured: during thrombectomy procedure
Thomboelastometry and prediction of thrombectomy efficacy
number of passes required for successful recanalization thrombolysis
Measured: immediatly after thrombectomy procedure
Thomboelastometry and prediction of thrombectomy efficacy
puncture to recanalization (minute)
Measured: 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)
Measured: just at the end of thrombectomy procedure
Prediction of success of thrombolysis
presence or absence of a clot on MRI or angioscan
Measured: "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.
Measured: "D0", "Day 1", "Day 3" after revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 May 2021 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Macrez, Doctor, Principal investigator, University hospital of Caen and faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870684
- Sponsor's protocol ID
- 2021-A00171-40
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sample and clinical could be share with private researcher (STAGO)
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04870684
- Acronym / sponsor ID
- 2021-A00171-40
- Keywords
- thromboelastometry, ischemic stroke, biomarker, thrombolysis, endovascular thrombectomy, Prediction of revascularization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sucess of revascularization | – | Other: thromboelastometry testgroup of patients for whom after thrombolysis neurological improvement will be observed and recanalization on imaging will be seen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 18 ans
- Formal contraindication to thrombolysis and/or endovascular thrombectomy, disorders of hemostasis and anticoagulant treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thromboelastometry testThis 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. | Other | sucess of revascularization |
Primary outcome
Prediction of the success of the revascularization procedure by thromboelastometry
Time frame: 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
Time frame: One hour after the blood test
clot firmness (MCF in millimeter, mm)
Prediction of the success of the revascularization procedure by thromboelastometry
Time frame: One hour after the blood test
clot lysis time (seconde).
6 secondary outcomes
Thomboelastometry and prediction of thrombolysis + thrombectomy efficacy
Time frame: during thrombectomy procedure
Thomboelastometry and prediction of thrombectomy efficacy
Time frame: immediatly after thrombectomy procedure
Thomboelastometry and prediction of thrombectomy efficacy
Time frame: through study completion, an average of 3 years
Thomboelastometry and prediction of success of recanalization by thrombectomy alone
Time frame: just at the end of thrombectomy procedure
Prediction of success of thrombolysis
Time frame: "Day 1", "Day 3" after thrombolysis
Thomboelastometry and prediction of neurological outcome
Time frame: "D0", "Day 1", "Day 3" after revascularization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: Yes. Sample and clinical could be share with private researcher (STAGO)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Macrez, Doctor principal investigator
University hospital of Caen and faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Stroke and Thrombolytic Therapy, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clémence h Tomadessos (+33231065386 ext. +33231065386, tomadesso-c@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of the success of the revascularization procedure by thromboelastometry (time frame: One hour after the blood test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.