Evaluation of Circulating Osteogenic Factors in Trauma Patients

Healthy Clinical Trial

— BMP-9  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01433536
• Other study ID #: 10-100
• Secondary ID: MOP-115149
• Status: Terminated
• Phase: N/A
• First received: September 12, 2011
• Last updated: January 23, 2018
• Start date: December 2010
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2018
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cranial Trauma
• Healthy
• High Velocity Fracture
• Spinal Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Canadian Institutes of Health Research (CIHR), Université de Sherbrooke

Country where clinical trial is conducted

Canada,