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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Nantes, France, 44000
- University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Spinal cord injury (SCI) patient
|
Venous Doppler ultrasound of the lower limbs at 6, 9 and 12 months of the initial injury
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC12_0137
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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