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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Centre Hospitalier Universitaire de Sherbrooke.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Guillaume Grenier, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01433536
First received: September 12, 2011
Last updated: September 13, 2011
Last verified: September 2011
  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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Sherbrooke:

Biospecimen Retention:   Samples Without DNA

blood samples


Estimated Enrollment: 60
Study Start Date: December 2010
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433536

Contacts
Contact: Amy Svotelis, Ph.D. 819-346-1110 ext 16194 asvotelis.chus@ssss.gouv.qc.ca
Contact: Gaelle Simon, Inf. 819-346-1110 ext 16194 gsimon.chus@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Amy Svotelis, Ph.D.    819-346-1110      
Sponsors and Collaborators
Centre Hospitalier Universitaire de Sherbrooke
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
  More Information

No publications provided

Responsible Party: Guillaume Grenier, Associate Professor, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01433536     History of Changes
Other Study ID Numbers: 10-100, MOP-115149
Study First Received: September 12, 2011
Last Updated: September 13, 2011
Health Authority: Canada: Health Canada
Canada: Canadian Institutes of Health Research

Keywords provided by Centre Hospitalier Universitaire 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:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014