Evaluation of Circulating Osteogenic Factors in Trauma Patients

NCT ID: NCT01433536

Last Updated: 2018-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2017-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy High Velocity Fracture Cranial Trauma Spinal Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

cranial trauma

Individuals presenting a cranial trauma that are classified at equal to or less than 8 on the Glasgow scale

No interventions assigned to this group

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

No interventions assigned to this group

spinal trauma

Individuals presenting a spinal fracture that are classified with an ASIA score of A, B, or C

No interventions assigned to this group

high velocity fracture, inferior limb

Individuals that present a fracture to the femur, tibia, or pelvis resulting from a high-velocity impact

No interventions assigned to this group

Control

Healthy individuals

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Guillaume Grenier

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillaume Grenier, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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MOP-115149

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10-100

Identifier Type: -

Identifier Source: org_study_id

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