Evaluation of Circulating Osteogenic Factors in Trauma Patients

NCT01433536 | Terminated DMC

• 2 other identifiers: 10-100MOP-115149
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; High Velocity Fracture; Cranial Trauma; Spinal Trauma

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

Study Arms (6)

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 Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• brain dead
• pathological fractures (cancer, osteoporosis)
• blood transfusion received
• pregnancy

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead
• Université de Sherbrooke: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

Study Officials

• Guillaume Grenier, Ph.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 14, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

CA (1)