Ischemic StrokeTRATTNCT02902263
Inter-Hospital Transfer to a Vascular Neurology Unit After Telethrombolysis
An observational study of Ischemic Stroke, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Early thrombolysis is essential in treating ischemic strokes. The time window for thrombolysis is limited to 4,5 hours after symptoms onset. In the French region of Franche Comté, in order to reduce the thrombolytic delay, a telemedicine network was developed between the neurovascular reference unit (NVU) localised in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jan 2016
- 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: Consecutive patients admitted in one emergency departments of four peripheral hospital centres in Franche Comté (Pontarlier, Vesoul, Gray and Dôle). Patients admitted for ischemic stroke, treated by thrombolysis and transferred to tue NVU
Who may be able to join
- Patient with ischaemic stroke
- Emergency department admission between 01/01/2012 and 12/31/2013
- Telemedicine stroke consult
- Thrombolysis therapy
- Patient transfered to NVU after thrombolysis initiation
- Transfer staffed by a qualified physician
Who cannot join
- Transfer non staffed by a qualified physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inter-Hospital Transfer to a Vascular Neurology Unit After Telethrombolysis in France Comté
Early thrombolysis is essential in treating ischemic strokes. The time window for thrombolysis is limited to 4,5 hours after symptoms onset.
In the French region of Franche Comté, in order to reduce the thrombolytic delay, a telemedicine network was developed between the neurovascular reference unit (NVU) localised in the University Hospital of Besançon and the peripheral hospital centres. Patients may then be transported to the NVU immediately after the thrombolysis initiation.
Read more
The aim of our study was to assess the relevance of a systematic medicalization of transfer to the NVU of patients with stroke who were telethrombolyzed before.
It was a retrospective, monocentric and observational study conducted over 24 months, in Franche-Comte (France).
Read the detailed description
Stroke is a major health problem with increasing incidence. It represents the leading cause of disability and the third cause of death in France. There are two main types of stroke: ischemic (80%) or hemorrhagic (20%).
Early thrombolysis is essential in treating ischemic strokes. The time window for thrombolysis is limited to 4,5 hours after symptoms onset.
In the French region of Franche Comté, in order to reduce the thrombolytic delay, a telemedicine network was developed between the neurovascular reference unit (NVU) localised in the University Hospital of Besançon and the peripheral hospital centres. Patients may then be transported to the NVU immediately after the thrombolysis initiation.
The aim of our study was to assess the relevance of a systematic medicalization of transfer to the NVU of patients with stroke who were telethrombolyzed before.
It was a retrospective, monocentric and observational study conducted over 24 months, in Franche-Comte (France). Evaluation of neurological status was made with the Glasgow score (GCS) and National Institute of Health Stroke Score (NIHSS). The respiratory (SpO2; needs O2) and hemodynamic status (arterial blood pressure, heart rate) were assessed as well as the need for medical resuscitation at different times of the transport (thrombolysis, transfer, arrival at the Regional University Hospital Centre).
- Conditions
- Ischemic Stroke
- Keywords
- Telemedecine, Thrombolysis
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient neurological status assessed by NIHSS score during transfer to NVU
Measured: one day
Patient neurological status assessed by Glasgow score during transfer to NVU
Measured: one day
Secondary outcomes (2)
Patient respiratory status assessed by oxygen saturation
Measured: one day
Patient hemodynamic status assessed by systolic and diastolic pressure
Measured: one day
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 startJan 2014
- Primary completionMay 2015
- Study completionJan 2016
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 Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902263
- Sponsor's protocol ID
- P/2015/248
- Acronym
- TRATT
- Status last verified
- Sep 2016
- First submitted
- 31 Aug 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Nenert E, Pretalli JB, Bouamra B, Puyraveau M, Fehner L, Labourey JM, Desmettre T. Transfert interhospitalier vers une unité de neurologie vasculaire des accidents vasculaires cérébraux ischémiques téléthrombolysés : pertinence d'une médicalisation systématique ? Ann. Fr. Med. Urgence (2016).
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-Hospital Transfer to a Vascular Neurology Unit After Telethrombolysis in France Comté
- ClinicalTrials.gov ID
- NCT02902263
- Acronym / sponsor ID
- TRATT / P/2015/248
- Conditions
- Ischemic Stroke
- Keywords
- Telemedecine, Thrombolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jan 2016 (actual)
- 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.
Early thrombolysis is essential in treating ischemic strokes. The time window for thrombolysis is limited to 4,5 hours after symptoms onset.
In the French region of Franche Comté, in order to reduce the thrombolytic delay, a telemedicine network was developed between the neurovascular reference unit (NVU) localised in the University Hospital of Besançon and the peripheral hospital centres. Patients may then be transported to the NVU immediately after the thrombolysis initiation.
The aim of our study was to assess the relevance of a systematic medicalization of transfer to the NVU of patients with stroke who were telethrombolyzed before.
It was a retrospective, monocentric and observational study conducted over 24 months, in Franche-Comte (France).
Detailed description
Stroke is a major health problem with increasing incidence. It represents the leading cause of disability and the third cause of death in France. There are two main types of stroke: ischemic (80%) or hemorrhagic (20%).
Early thrombolysis is essential in treating ischemic strokes. The time window for thrombolysis is limited to 4,5 hours after symptoms onset.
In the French region of Franche Comté, in order to reduce the thrombolytic delay, a telemedicine network was developed between the neurovascular reference unit (NVU) localised in the University Hospital of Besançon and the peripheral hospital centres. Patients may then be transported to the NVU immediately after the thrombolysis initiation.
The aim of our study was to assess the relevance of a systematic medicalization of transfer to the NVU of patients with stroke who were telethrombolyzed before.
It was a retrospective, monocentric and observational study conducted over 24 months, in Franche-Comte (France). Evaluation of neurological status was made with the Glasgow score (GCS) and National Institute of Health Stroke Score (NIHSS). The respiratory (SpO2; needs O2) and hemodynamic status (arterial blood pressure, heart rate) were assessed as well as the need for medical resuscitation at different times of the transport (thrombolysis, transfer, arrival at the Regional University Hospital Centre).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted in one emergency departments of four peripheral hospital centres in Franche Comté (Pontarlier, Vesoul, Gray and Dôle). Patients admitted for ischemic stroke, treated by thrombolysis and transferred to tue NVU
Key inclusion criteria (6 listed)
- Patient with ischaemic stroke
- Emergency department admission between 01/01/2012 and 12/31/2013
- Telemedicine stroke consult
- Thrombolysis therapy
- Patient transfered to NVU after thrombolysis initiation
Key exclusion criteria (1 listed)
- Transfer non staffed by a qualified physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient neurological status assessed by NIHSS score during transfer to NVU
Time frame: one day
Patient neurological status assessed by Glasgow score during transfer to NVU
Time frame: one day
2 secondary outcomes
Patient respiratory status assessed by oxygen saturation
Time frame: one day
Patient hemodynamic status assessed by systolic and diastolic pressure
Time frame: one day
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 27 Jan 2020.
- Results publicationNenert E, Pretalli JB, Bouamra B, Puyraveau M, Fehner L, Labourey JM, Desmettre T. Transfert interhospitalier vers une unité de neurologie vasculaire des accidents vasculaires cérébraux ischémiques téléthrombolysés : pertinence d'une médicalisation systématique ? Ann. Fr. Med. Urgence (2016).
- Individual participant dataSharing planned: Undecided
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ischemic Stroke, run by Centre Hospitalier Universitaire de Besancon 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 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: finished, as of the sponsor's last update on 27 Jan 2020. 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?
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?
Patient neurological status assessed by NIHSS score during transfer to NVU (time frame: one day). The study lists 2 primary outcomes in all. 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 NCT02902263, 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 27 Jan 2020.