StrokeROTEMPredictNCT02902393
Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke
An observational study of Stroke, run by University Hospital, Caen at 1 site in France.
Trial summary
Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Thromboelastography
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Sep 2018
- 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: All patients meeting the eligibility criteria will be invited to participate in the study . Patients will be recruited to emergencies CHU Caen and Saint Joseph Hospital. The goal is to recruit patients with neurological defect consistent with a neurovascular pathology eligible for thrombolysis with tPA. With the admission of patients, blood samples are routinely made . For this study, the investigators will add one citrated 5 mL tube. An information letter and consent form will be given to the patient.
Who may be able to join
- Patient (> 18 years) with a neurological deficit compatible with a neurovascular pathology eligible for fibrinolysis rtPA and having a proximal occlusion of the middle cerebral artery (segment M1 / M2) or basilar trunk objectified brain imaging (MRI angiography or angio CT).
Who cannot join
- Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Caen, Calvados, 14000
Christophe Kassel, 0231063106 ext. +33, directiongenerale@chu-caen.fr
About this study
Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy.
The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.
- Conditions
- Stroke
- Being tested
- Thromboelastography
- Keywords
- Fibrinolysis, tPA
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyBiological
| Study group | Role | What they receive |
|---|---|---|
| Success of revascularisation | Not described Receives: Biological: Thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI
Measured: 24 hours
Secondary outcomes (1)
Clinical evaluation using NIHSS scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard MACREZ, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902393
- Sponsor's protocol ID
- 15-202
- Acronym
- ROTEMPredict
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke
- ClinicalTrials.gov ID
- NCT02902393
- Acronym / sponsor ID
- ROTEMPredict / 15-202
- Conditions
- Stroke
- Keywords
- Fibrinolysis, tPA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 15 Sep 2016 (estimated)
- 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.
Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy.
The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Success of revascularisation | – | Biological: Thromboelastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the eligibility criteria will be invited to participate in the study . Patients will be recruited to emergencies CHU Caen and Saint Joseph Hospital. The goal is to recruit patients with neurological defect consistent with a neurovascular pathology eligible for thrombolysis with tPA. With the admission of patients, blood samples are routinely made . For this study, the investigators will add one citrated 5 mL tube. An information letter and consent form will be given to the patient.
Key inclusion criteria (1 listed)
- Patient (> 18 years) with a neurological deficit compatible with a neurovascular pathology eligible for fibrinolysis rtPA and having a proximal occlusion of the middle cerebral artery (segment M1 / M2) or basilar trunk objectified brain imaging (MRI angiography or angio CT).
Key exclusion criteria (1 listed)
- Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).
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 |
|---|---|---|
| Thromboelastography | Biological | Success of revascularisation |
Primary outcome
Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI
Time frame: 24 hours
1 secondary outcome
Clinical evaluation using NIHSS scale
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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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, PhD principal investigator
University Hospital, Caen
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 Stroke, 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 1 inclusion and 1 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 15 Sep 2016. 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 Yohann REPESSE, MD PhD (+330231063315, repesse-y@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI (time frame: 24 hours). 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 15 Sep 2016.