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Trial record 24 of 1168 for:    spinal cord injury

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)

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ClinicalTrials.gov Identifier: NCT02796235
Recruitment Status : Unknown
Verified June 2016 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: Venous Doppler ultrasound of the lower limbs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : November 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : August 2017

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Arm Intervention/treatment
Spinal cord injury (SCI) patient 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




Primary Outcome Measures :
  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 [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796235


Locations
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France
University Hospital Recruiting
Nantes, France, 44000
Contact: Brigitte PERROUIN-VERBE, Professor    +33 2 40 84 60 66    brigitte.perrouinverbe@chu-nantes.fr   
Principal Investigator: Brigitte PERROUIN-VERBE, Professor         
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02796235     History of Changes
Other Study ID Numbers: RC12_0137
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Thromboembolism
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases