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OpenTrials
Completed

NCT Number: NCT04446325

Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis

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.

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Key information

Conditions

Lateral Amyotrophic Sclerosis Amyotrophic Lateral Sclerosis Cardiovascular Diseases Central Nervous System Diseases Embolism Embolism and Thrombosis Lung Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Pulmonary Embolism Respiratory Tract Diseases Spinal Cord Diseases TDP-43 Proteinopathies Thrombosis Vascular Diseases Venous Thrombo-embolic Desease Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

    Time frame: 19 years

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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: TESLA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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