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)

Nantes University Hospital (NUH)

Status

Terminated

Conditions

Spinal Cord Injury

Treatments

Other: Venous Doppler ultrasound of the lower limbs

Study type

Interventional

Funder types

Other

Identifiers

NCT02796235

RC12_0137

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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