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TESLA: Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT04446325
Collaborator
(none)
227
Enrollment
1
Location
2
Actual Duration (Months)
113.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    227 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis
    Actual Study Start Date :
    Mar 1, 2020
    Actual Primary Completion Date :
    Mar 1, 2020
    Actual Study Completion Date :
    May 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Number of venous thrombo-embolic eventsrate per year in amyotrophic lateral sclerosis patients followed between 2000 and 2019 in Brest universitary hospital [19 years]

      pulmonary embolism and deep venous thrombosis

    Secondary Outcome Measures

    1. Number of predictiv factors of venous thrombo-embolism events in amyotrophic lateral sclerosis population followed in Brest universitary hospital between 2000 and 2019 [19 years]

      immobilization, impairment of respiratory function,, mecanical ventilation, denutrition, artificial nutrition

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04446325
    Other Study ID Numbers:
    • 29BRC19.0236
    First Posted:
    Jun 24, 2020
    Last Update Posted:
    Sep 11, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    lateral amyotrophic sclerosis
    venous thrombo-embolic desase
    pulmonary embolism
    deep venous thrombosis
    Additional relevant MeSH terms:
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis
    Thromboembolism
    Sclerosis

    Study Results

    No Results Posted as of Sep 11, 2020