Lateral Amyotrophic Sclerosis Clinical Trial
— TESLAOfficial title:
Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis
| NCT number | NCT04446325 |
| Other study ID # | 29BRC19.0236 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 1, 2020 |
| Est. completion date | May 1, 2020 |
| Verified date | September 2020 |
| Source | University Hospital, Brest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 227 |
| Est. completion date | May 1, 2020 |
| Est. primary completion date | March 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria followed in competence centre of Brest Universitary Hospital during 2000 to 2019 Exclusion Criteria: - no consent - other neuro-degenerativ diseases |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU de Brest | Brest |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 19 years | |
| Secondary | 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 | 19 years |