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

NCT02796235 | Terminated

• 1 other identifier: RC12_0137
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Spinal cord injury (SCI) patient

OTHER

Other: Venous Doppler ultrasound of the lower limbs

Interventions

Venous Doppler ultrasound of the lower limbs OTHER

Venous Doppler ultrasound of the lower limbs at 6, 9 and 12 months of the initial injury

Spinal cord injury (SCI) patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, 44000, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 10, 2016
• Study Start: November 8, 2012
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)