Lateral Amyotrophic SclerosisTESLANCT04446325
Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis
An observational study of Lateral Amyotrophic Sclerosis and Venous Thrombo-embolic Desease, run by University Hospital, Brest at 1 site in France.
Trial summary
Venous thrombo-embolic (VTE) rates could be high in patients with amyotrophic lateral sclerosis (ALS). Indeed, the rate of VTE in this specific population could be 7-fold higher in this population. Predictiv factors of VTE in patients with ALS are mobility reduction and neurological paralysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lateral Amyotrophic Sclerosis, Venous Thrombo-embolic Desease
- How many people
- 227 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria followed in competence centre of brest universitary hospital during 2000 to 2019
Who may be able to join
- patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria followed in competence centre of Brest Universitary Hospital during 2000 to 2019
Who cannot join
- no consent
- other neuro-degenerativ diseases
Trial locations and contacts
1 site in 1 country.
About this study
Venous thrombo-embolic (VTE) rates could be high in patients with amyotrophic lateral sclerosis (ALS). Indeed, the rate of VTE in this specific population could be 7-fold higher in this population. Predictiv factors of VTE in patients with ALS are mobility reduction and neurological paralysis. However, to our knowledge, medical littérature is poor concerning VTE and ALS association.
Our first aim is to define annual rate of VTE in ALS population.Then we aim to identify predictiv factors of VTE in this specific population. The studied population is Brest universitary hospital cohort of ALS patient included between 2000 and 2019.
- Keywords
- lateral amyotrophic sclerosis, venous thrombo-embolic desase, pulmonary embolism, deep venous thrombosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Pulmonary Embolism, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of venous thrombo-embolic eventsrate per year in amyotrophic lateral sclerosis patients followed between 2000 and 2019 in Brest universitary hospital
pulmonary embolism and deep venous thrombosis
Measured: 19 years
Secondary outcomes (1)
Number of predictiv factors of venous thrombo-embolism events in amyotrophic lateral sclerosis population followed in Brest universitary hospital between 2000 and 2019
immobilization, impairment of respiratory function,, mecanical ventilation, denutrition, artificial nutrition
Measured: 19 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Amyotrophic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446325
- Sponsor's protocol ID
- 29BRC19.0236
- Acronym
- TESLA
- Status last verified
- Sep 2020
- First submitted
- 22 Jun 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT04446325
- Acronym / sponsor ID
- TESLA / 29BRC19.0236
- Keywords
- lateral amyotrophic sclerosis, venous thrombo-embolic desase, pulmonary embolism, deep venous thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 24 Jun 2020 (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.
Venous thrombo-embolic (VTE) rates could be high in patients with amyotrophic lateral sclerosis (ALS). Indeed, the rate of VTE in this specific population could be 7-fold higher in this population. Predictiv factors of VTE in patients with ALS are mobility reduction and neurological paralysis. However, to our knowledge, medical littérature is poor concerning VTE and ALS association.
Our first aim is to define annual rate of VTE in ALS population.Then we aim to identify predictiv factors of VTE in this specific population. The studied population is Brest universitary hospital cohort of ALS patient included between 2000 and 2019.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria followed in competence centre of brest universitary hospital during 2000 to 2019
Key inclusion criteria (1 listed)
- patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria followed in competence centre of Brest Universitary Hospital during 2000 to 2019
Key exclusion criteria (2 listed)
- no consent
- other neuro-degenerativ diseases
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
Number of venous thrombo-embolic eventsrate per year in amyotrophic lateral sclerosis patients followed between 2000 and 2019 in Brest universitary hospital
Time frame: 19 years
pulmonary embolism and deep venous thrombosis
1 secondary outcome
Number of predictiv factors of venous thrombo-embolism events in amyotrophic lateral sclerosis population followed in Brest universitary hospital between 2000 and 2019
Time frame: 19 years
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 11 Sep 2020.
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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.
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 Lateral Amyotrophic Sclerosis and Venous Thrombo-embolic Desease, run by University Hospital, Brest 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 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: finished, as of the sponsor's last update on 11 Sep 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?
Number of venous thrombo-embolic eventsrate per year in amyotrophic lateral sclerosis patients followed between 2000 and 2019 in Brest universitary hospital (time frame: 19 years). 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 11 Sep 2020.