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Evaluation of Circulating Osteogenic Factors in Trauma Patients (BMP-9)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433536
First Posted: September 14, 2011
Last Update Posted: January 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Guillaume Grenier, Université de Sherbrooke
  Purpose

Bone fractures in traumatic brain-injured and spinal cord-injured patients often heal faster than in other patients. However, such patients are also occasionally prone to bone formation in soft tissues such as muscle. This process is called heterotopic ossification and tends to occur around joints. Patients with heterotopic ossification often suffer from complications such nerve compression, ankylosis, chronic pain, osteoporosis, and infections. Loss of movement can also interfere with function and the quality of life of patients already experiencing difficulties associated with their trauma. Positioning, transfers, and hygiene become difficult and even impossible, which worsens the loss of autonomy.

Previous research has suggested that an osteoinductive factor (which has the capacity to induce the formation of bone) may be released into the bloodstream following a head or spinal cord injury. The investigators laboratory has shown that a growth factor called BMP-9, when injected into a damaged mouse muscle, has the ability to cause strong ossification in damaged muscle. The investigators would like to find out whether the levels of BMP-9 and/or its receptor (which is called ALK1) increase after traumatic brain and spinal cord injuries that occur at the same time as serious orthopaedic traumas.

The main goal of the investigators study is thus to determine whether BMP-9 levels increase in the serum of trauma patients.


Condition
Healthy High Velocity Fracture Cranial Trauma Spinal Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Circulating Osteogenic Factors in Trauma Patients (BMP-9)

Resource links provided by NLM:


Further study details as provided by Guillaume Grenier, Université de Sherbrooke:

Biospecimen Retention:   Samples Without DNA
blood samples

Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
cranial trauma and fracture
Individuals presenting a cranial trauma that are classified at equal to or less than 8 on the Glasgow scale, combined with a fracture to the femur, tibia, or pelvis resulting from a high-velocity impact
cranial trauma
Individuals presenting a cranial trauma that are classified at equal to or less than 8 on the Glasgow scale
spinal trauma with fracture
Individuals presenting a spinal fracture that are classified with an ASIA score of A, B, or C, combined with a fracture to the femur, tibia, or pelvis resulting from a high-velocity impact
spinal trauma
Individuals presenting a spinal fracture that are classified with an ASIA score of A, B, or C
high velocity fracture, inferior limb
Individuals that present a fracture to the femur, tibia, or pelvis resulting from a high-velocity impact
Control
Healthy individuals

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients arriving at the emergency room at the CHUS that present pathologies associated with the different cohorts described and responding to inclusion criteria.
Criteria

Inclusion Criteria:

  • cranial trauma with Glasgow =< 8
  • spinal trauma with ASIA A, B, C
  • high-velocity fracture of femur, tibia, pelvis

Exclusion Criteria:

  • brain dead
  • pathological fractures (cancer, osteoporosis)
  • blood transfusion received
  • pregnancy
  Contacts and Locations
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): NCT01433536


Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Guillaume Grenier, Ph.D. Université de Sherbrooke
  More Information

Responsible Party: Guillaume Grenier, Associate Professor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01433536     History of Changes
Other Study ID Numbers: 10-100
MOP-115149 ( Other Grant/Funding Number: CIHR )
First Submitted: September 12, 2011
First Posted: September 14, 2011
Last Update Posted: January 27, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Guillaume Grenier, Université de Sherbrooke:
cranial trauma with or without high velocity fracture to inferior limb
spinal trauma with or without high velocity fracture to inferior limb
high velocity fracture to inferior limb

Additional relevant MeSH terms:
Wounds and Injuries