Back to resultsProspective 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)
Primary Purpose
Spinal Cord Injury
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Venous Doppler ultrasound of the lower limbs
Sponsored by
About this trial
This is an interventional other trial for Spinal Cord Injury
Eligibility Criteria
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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Spinal cord injury (SCI) patient
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02796235
Brief 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
Acronym
IMATEM
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 Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulties of recruitment
Study Start Date
November 8, 2012 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal cord injury (SCI) patient
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Venous Doppler ultrasound of the lower limbs
Intervention Description
Venous Doppler ultrasound of the lower limbs at 6, 9 and 12 months of the initial injury
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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