Prospective and Monocentric Study of the Incidence of Venous Thromboembolic Disease (VTE) in Spinal Cord Injury (SCI) Patient Between 3 and 12 Months After SCI
NCT ID: NCT02796235
Last Updated: 2021-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
81 participants
INTERVENTIONAL
2012-11-08
2019-08-08
Brief Summary
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The risk of VTE is very important in the first weeks after spinal cord injury, and then declines with a prevalence of VTE slightly higher than the general population after 12 weeks. However there is no prospective study of incidence of VTE in SCI patients after 3 months. The investigators wish to conduct such a study during the year following spinal cord injury with performing venous Doppler ultrasound of the lower limbs 6, 9 and 12 months of the initial injuryassociated with a standardized clinical assessment, to know the incidence of VTE and determine prognostic factors for VTE.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Spinal cord injury (SCI) patient
Venous Doppler ultrasound of the lower limbs
Venous Doppler ultrasound of the lower limbs at 6, 9 and 12 months of the initial injury
Interventions
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Venous Doppler ultrasound of the lower limbs
Venous Doppler ultrasound of the lower limbs at 6, 9 and 12 months of the initial injury
Eligibility Criteria
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Inclusion Criteria
* Patients having paraplegia or tetraplegia from C2 levels and above S1
* Paraplegia and tetraplegia of traumatic or non progressive SCI from traumatic or medical origin (ischemic, post-surgical, myelitis, benign tumor)
* Informed consent signed.
* stabilized respiratory situation with absence of chronic hypoxemia (hypoxemia being characterized by PaO2 steady state \<7.33 kPa)
* Patient not amputated.
* Absence of heart failure with ejection fraction below 30%
* Lack of solid neoplasia or progressive lymphoid haemopathy for 5 years, or myeloproliferative disorders (including polycythemia and thrombocythemia).
* No personal history of VTE and / or thrombophilia before the injury.
Exclusion Criteria
* Amputated Patient.
* Patients with heart failure with ejection fraction below 30%
* Solid neoplasia or progressive lymphoid haemopathy for 5 years, or myeloproliferative disorders (including polycythemia and thrombocythemia).
* Personal history of VTE and / or thrombophilia before the injury.
* Can not to follow during the study period
* Pregnant women
* Patient Refusal
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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University Hospital
Nantes, , France
Countries
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Other Identifiers
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RC12_0137
Identifier Type: -
Identifier Source: org_study_id
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