Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury
Completed
- Conditions
- TraumaAcquired Bleeding Disorder
- Interventions
- Drug: activated recombinant human factor VII
- Registration Number
- NCT00124293
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- Ages Eligible for Study: 18 Years - 85 Years
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Factor VII activated recombinant human factor VII -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which activated recombinant human factor VII influences haemorrhagic progression in traumatic brain injury patients?
How does the use of activated recombinant human factor VII compare to standard-of-care treatments in managing cerebral contusions and bleeding post-TBI?
Which biomarkers are associated with response prediction or risk stratification for haemorrhagic progression in traumatic brain injury patients treated with activated factor VII?
What are the known adverse events and management strategies for activated recombinant human factor VII in traumatic brain injury and acquired bleeding disorders?
Are there combination approaches or competitor drugs to activated factor VII for treating traumatic brain injury-related cerebral contusions?
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇦Mississauga, Canada
Novo Nordisk Investigational Site🇨🇦Mississauga, Canada