HealthyBMP-9NCT01433536
Evaluation of Circulating Osteogenic Factors in Trauma Patients
An observational study of Healthy and High Velocity Fracture, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, High Velocity Fracture, Cranial Trauma
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- cranial trauma with Glasgow =< 8
- spinal trauma with ASIA A, B, C
- high-velocity fracture of femur, tibia, pelvis
Who cannot join
- brain dead
- pathological fractures (cancer, osteoporosis)
- blood transfusion received
- pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startDec 2010
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Why it stopped: Guillaume Grenier, principal investigator is no longer working at the lab. The lab is now closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Sherbrooke, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Guillaume Grenier, Université de Sherbrooke
- Investigators
- Guillaume Grenier, Ph.D., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433536
- Sponsor's protocol ID
- 10-100
- Other IDs
- MOP-115149
- Acronym
- BMP-9
- Status last verified
- Jan 2018
- First submitted
- 12 Sep 2011
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circulating Osteogenic Factors in Trauma Patients (BMP-9)
- ClinicalTrials.gov ID
- NCT01433536
- Acronym / sponsor ID
- BMP-9 / 10-100
- 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 type
- Observational
- Recruitment status
- TerminatedReason stopped: Guillaume Grenier, principal investigator is no longer working at the lab. The lab is now closed.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Collaborators
- Université de Sherbrooke, Canadian Institutes of Health Research (CIHR)
- Study start
- Dec 2010
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- cranial trauma with Glasgow =< 8
- spinal trauma with ASIA A, B, C
- high-velocity fracture of femur, tibia, pelvis
Key exclusion criteria (4 listed)
- brain dead
- pathological fractures (cancer, osteoporosis)
- blood transfusion received
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Guillaume Grenier, principal investigator is no longer working at the lab. The lab is now closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Grenier, Ph.D. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and High Velocity Fracture, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Guillaume Grenier, principal investigator is no longer working at the lab. The lab is now closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.