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 (IMATEM)
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|ClinicalTrials.gov Identifier: NCT02796235|
Recruitment Status : Unknown
Verified June 2016 by Nantes University Hospital.
Recruitment status was: Recruiting
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Other: Venous Doppler ultrasound of the lower limbs||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||August 2017|
|Spinal cord injury (SCI) patient||
Other: Venous Doppler ultrasound of the lower limbs
Venous Doppler ultrasound of the lower limbs at 6, 9 and 12 months of the initial injury
- 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 [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796235
|Nantes, France, 44000|
|Contact: Brigitte PERROUIN-VERBE, Professor +33 2 40 84 60 66 firstname.lastname@example.org|
|Principal Investigator: Brigitte PERROUIN-VERBE, Professor|