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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Healthy; High Velocity Fracture; Cranial Trauma; Spinal Trauma

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	40 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Official Title:	Evaluation of Circulating Osteogenic Factors in Trauma Patients (BMP-9)
Study Start Date :	December 2010
Actual Primary Completion Date :	December 1, 2017
Actual Study Completion Date :	December 1, 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples Without DNA

blood samples

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted:	September 14, 2011
Last Update Posted:	January 24, 2018
Last Verified:	January 2018
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