Acute StrokePhase 4NCT00279149
TRUST-tPA: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) of Patients With Acute Stroke
A Phase 4 study testing Visio conference system connected to the Tele-stroke network in people with Acute Stroke, run by Assistance Publique - Hôpitaux de Paris at 9 sites in France.
Trial summary
The objective is to evaluate decision making of i.v. tPA treatment in acute stroke within 3 hours of symptom onset either remotely via videoconferencing system (investigational arm) beginning of treatment on-site and then transfer to stroke unit vs. decision after immediate transfer to stroke unit (usual care arm). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Visio conference system connected to the Tele-stroke network
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 9 sitesFrance
- Study dates
- Mar 2006to Oct 2010
- Phase
- Phase 4
- 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
Who may be able to join
- patients older than 18 years
- symptoms of brain infarction since less than 150 minutes
- NIHSS between 4 and 22
- No brain hemorrhage on contrast CT-scan
- Signed consent form by the patient or his relatives
Who cannot join
- NIHSS above 22 or coma
- current oral anticoagulant or INR > 1.7
- heparin treatment within the preceding 24 hours or prolonged APTT (>40seconds)
- platelets count < 100 000/mm3
- another stroke or brain trauma within 3 months prior admission
- systolic blood pressure > 185 or diastolic blood pressure > 110 at the time od tPA treatment onset
Show all 22Show fewer
- neurologic deficit is improving
- history of intracranial hemorrhage
- glycemia less than 0.5g/l or upper than 4g/l after treatment by Actrapid
- epileptic seizure at the time of stroke onset
- Gastro-intestinal or urinary hemorrhage
- Recent myocardial infarction within the last 21 days
- Lumbar puncture or arterial blood sampling in a non compressible vessel within the last 7 days
- Hemophilia
- Pregnancy or breast feeding
- Pericarditis within the last 3 months
- Major surgery within the last 15 days
- History of aortic dissection
- Endocarditis with the last 3 months
- Brain CT scan exclusion criteria:
- Mass effect ( tumor, VAM, aneurism )
- Decreased density ( ASPECTS score < 8) or mass effect involving more than 1/3 of the territory of the middle cerebral artery
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hôpital d'Argenteuil, Emergency Unit
Argenteuil, 95100
Hôpital Avicenne, Emergency Unit
Bobigny, 93000
Hôpital Ambroise Paré, Emergency Unit
Boulogne, 92100
Hôpital Beaujon, Emergency Unit
Clichy, 92110
Hôpital Louis Mourier, Emergency Unit
Colombes, 92700
Hôpital de Compiègne, Emergency Unit
Compiègne, 60200
Hôpital de Lagny sur Marne, Emergency Unit
Lagny, 77400
BICHAT HOSPITAL Departement of Neurology
Paris, 75018
Hôpital de Provins, Emergency Unit
Provins, 77160
About this study
Official title: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) in the Management of Patient With Acute Stroke Within 3-hour After Their Symptom Onset Who Are Admitted to a Remote Hospital With no Stroke Unit Facility
The objective is to evaluate decision making of i.v. tPA treatment in acute stroke within 3 hours of symptom onset either remotely via videoconferencing system (investigational arm) beginning of treatment on-site and then transfer to stroke unit vs. decision after immediate transfer to stroke unit (usual care arm). Ten remote hospitals are connected to the BICHAT stroke unit. All patients will have stroke unit care at BICHAT hospital. Primary end-point is rankin 0-1 at 3 months.
Read the detailed description
This study is a therapeutic trial, comparing a TELESTROKE decision making as the tested hypothesis to usual care (immediate transfer to stroke unit). Once the ER doctor in one of the 10 remote hospitals will judge his patient eligible for tPA thrombolysis, he will call the BICHAT stroke unit visio-conference system. Then, according to the randomization list, the patient will be allocated to 'standard care arm' which is the EMEA-approved tPA labeling (i.e., transfer the patient immediately to a stroke unit to have tPA thrombolysis if the patient arrives in due time -before 3 hours of stroke onset) or he will be allocated to 'TELESTROKE ARM"(i.e., remote neurological exam to perform NIHSS, assess the exact time of the first stroke symptoms onset and visualization of brain CT-scan by the vascular neurologist; then start the tPA thrombolysis on site if the indication is confirmed by the vascular neurologist, then transfer the patient to the BICHAT stroke unit). The primary outcome will be Rankin 0-1 (i.e., cured) at 3 months; secondary outcome will be death or dependency at 3 months and the frequency of symptomatic intracranial hemorrhage at 10 days. Patients randomized will be systematically transfer to the BICHAT stroke unit, no matter the received or not tPA thrombolysis, and no matter the study arm, according to the intention-to-treat rule.
- Conditions
- Acute Stroke
- Being tested
- Visio conference system connected to the Tele-stroke network
- Keywords
- Telemedicine, TELESTROKE, symptoms of ischemic stroke since less than 3 hours
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visio conference system connected to the Tele-stroke networkProcedure or surgery
Visio conference system connected to the Tele-stroke network
| Study group | Role | What they receive |
|---|---|---|
| surgery | Experimental | surgery Receives: Procedure: Visio conference system connected to the Tele-stroke network |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients cured at 3 months (rankin score 0,1)
Percentage of patients cured at 3 months (rankin score 0,1)
Measured: at 3 months
Secondary outcomes (2)
NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,
NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,
Measured: at 3 months
percentage of symptomatic intracranial hemorrhage at 8 days
percentage of symptomatic intracranial hemorrhage at 8 days
Measured: at 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Pierre AMARENCO, Pr,MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279149
- Sponsor's protocol ID
- P 030443
- Status last verified
- Feb 2007
- First submitted
- 13 Jan 2006
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mazighi M, Meseguer E, Labreuche J, Miroux P, Le Gall C, Roy P, Tubach F, Amarenco P. TRUST-tPA trial: Telemedicine for remote collaboration with urgentists for stroke-tPA treatment. J Telemed Telecare. 2017 Jan;23(1):174-180. doi: 10.1177/1357633X15615762. Epub 2016 Jul 9.
PubMed 26656722
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) in the Management of Patient With Acute Stroke Within 3-hour After Their Symptom Onset Who Are Admitted to a Remote Hospital With no Stroke Unit Facility
- ClinicalTrials.gov ID
- NCT00279149
- Acronym / sponsor ID
- P 030443
- Conditions
- Acute Stroke
- Keywords
- Telemedicine, TELESTROKE, symptoms of ischemic stroke since less than 3 hours
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Jan 2006 (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.
The objective is to evaluate decision making of i.v. tPA treatment in acute stroke within 3 hours of symptom onset either remotely via videoconferencing system (investigational arm) beginning of treatment on-site and then transfer to stroke unit vs. decision after immediate transfer to stroke unit (usual care arm). Ten remote hospitals are connected to the BICHAT stroke unit. All patients will have stroke unit care at BICHAT hospital. Primary end-point is rankin 0-1 at 3 months.
Detailed description
This study is a therapeutic trial, comparing a TELESTROKE decision making as the tested hypothesis to usual care (immediate transfer to stroke unit). Once the ER doctor in one of the 10 remote hospitals will judge his patient eligible for tPA thrombolysis, he will call the BICHAT stroke unit visio-conference system. Then, according to the randomization list, the patient will be allocated to 'standard care arm' which is the EMEA-approved tPA labeling (i.e., transfer the patient immediately to a stroke unit to have tPA thrombolysis if the patient arrives in due time -before 3 hours of stroke onset) or he will be allocated to 'TELESTROKE ARM"(i.e., remote neurological exam to perform NIHSS, assess the exact time of the first stroke symptoms onset and visualization of brain CT-scan by the vascular neurologist; then start the tPA thrombolysis on site if the indication is confirmed by the vascular neurologist, then transfer the patient to the BICHAT stroke unit). The primary outcome will be Rankin 0-1 (i.e., cured) at 3 months; secondary outcome will be death or dependency at 3 months and the frequency of symptomatic intracranial hemorrhage at 10 days. Patients randomized will be systematically transfer to the BICHAT stroke unit, no matter the received or not tPA thrombolysis, and no matter the study arm, according to the intention-to-treat rule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | Experimental | Procedure: Visio conference system connected to the Tele-stroke networksurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients older than 18 years
- symptoms of brain infarction since less than 150 minutes
- NIHSS between 4 and 22
- No brain hemorrhage on contrast CT-scan
- Signed consent form by the patient or his relatives
Key exclusion criteria (22 listed)
- NIHSS above 22 or coma
- current oral anticoagulant or INR > 1.7
- heparin treatment within the preceding 24 hours or prolonged APTT (>40seconds)
- platelets count < 100 000/mm3
- another stroke or brain trauma within 3 months prior admission
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 |
|---|---|---|
| Visio conference system connected to the Tele-stroke networkVisio conference system connected to the Tele-stroke network | Procedure or surgery | surgery |
Primary outcome
Percentage of patients cured at 3 months (rankin score 0,1)
Time frame: at 3 months
Percentage of patients cured at 3 months (rankin score 0,1)
2 secondary outcomes
NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,
Time frame: at 3 months
percentage of symptomatic intracranial hemorrhage at 8 days
Time frame: at 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
- Derived from this study: PubMed 26656722Mazighi M, Meseguer E, Labreuche J, Miroux P, Le Gall C, Roy P, Tubach F, Amarenco P. TRUST-tPA trial: Telemedicine for remote collaboration with urgentists for stroke-tPA treatment. J Telemed Telecare. 2017 Jan;23(1):174-180. doi: 10.1177/1357633X15615762. Epub 2016 Jul 9.
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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.
Pierre AMARENCO, Pr,MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Visio conference system connected to the Tele-stroke network in people with Acute Stroke, run by Assistance Publique - Hôpitaux de Paris at 9 sites 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 5 inclusion and 22 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: finished, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients cured at 3 months (rankin score 0,1) (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279149, which also lists 1 linked publication.
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 17 Feb 2011.