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

Spinal Cord Injury Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02796235
• Other study ID #: RC12_0137
• Status: Terminated
• Phase: N/A
• Start date: November 8, 2012
• Est. completion date: August 8, 2019

Study information

• Verified date: May 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: August 8, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Thromboembolism
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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