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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy; Spinal Trauma; High Velocity Fracture; Cranial Trauma

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Control; Healthy individuals
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

Collaborators and Investigators

• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Collaborators: Canadian Institutes of Health Research (CIHR); Université de Sherbrooke
• Investigators: Principal Investigator: Guillaume Grenier, Ph.D., Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: September 12, 2011
• First Submitted That Met QC Criteria: September 13, 2011
• First Posted (Estimate): September 14, 2011

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: 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
• Other Study ID Numbers: 10-100; MOP-115149 (Other Grant/Funding Number: CIHR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED