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

Not Applicable

Terminated

• Conditions: Spinal Cord Injury
• Interventions: Other: Venous Doppler ultrasound of the lower limbs

• Registration Number: NCT02796235
• Lead Sponsor: Nantes University Hospital

Brief Summary

Venous Thromboembolic Disease (VTE) in SCI patients is very common, its prevalence is 60 to 80% against 10-20% in the general population.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11-08
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-10
• Primary Completion: 2019-08-08
• Study Completion: 2019-08-08
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Age greater than 18 years.
• 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.

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Exclusion Criteria

• Unstabilized respiratory situation with presence of chronic hypoxemia (hypoxemia being characterized by PaO2 steady state <7.33 kPa)
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal cord injury (SCI) patient	Venous Doppler ultrasound of the lower limbs	-

Primary Outcome Measures

Name	Time	Method
Number of appearances of phlebitis in the lower limbs and / or pulmonary embolism in spinal cord injury (SCI) patient between 3 and 12 months after SCI	12 months

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France