Contusive Brain Injury MedDRA version: 6.1 Level: LLT Classification code 10052346
Conditions
Interventions
Trade Name: NovoSeven®
Product Name: NovoSeven®
Product Code: rFVIIa
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Eptacog alfa (activated)
Current Sponsor c
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). Signed informed consent may be obtained either from the subject and/or his/her legally acceptable representative (LAR). 2. Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset. 3. Head CT scan showing intraparencymal haemorrhage (one or more contusions) with a total minimum volume of greater than or equal to 2ml and at least one single intraparenchymal haemorrhage greater than or equal to 1ml as detected determined by the ABC/2 method. 4. Male or female subjects, age 18 years or over. 5.GCS between 4 and 14 (both inclusive) or if GCS cannot be assessed: a motor score of 2-5 (both inclusive). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Life expectancy less than 24 hours after injury 2. Any planned surgery of parenchymal lesions in the brain within 24 hours of dosing 3. Time of CBI unknown or > 6 hours prior to initial CT scan 4. Penetrating brain injury (e.g. gunshot wounds, stab wounds) 5. Body weight greater than or equal to 160 kg 6. Spinal cord injury 7. The following CT findings in isolation: pure subarachnoid haemorrhage, pure intra-ventricular haemorrhage, pure epidural haemorrhage pure subdural haemorrhage or suspicion of a spontaneous intracerebral haemorrhage 8. Subjects with significant cardiovascular dysfunction or haemodynamic instability due to haemorrhage, e.g. systolic blood pressure ? 90 mmHg and/or red blood cell transfusion needed to maintain haemodynamic stability before the initial CT scan 9. Subjects scheduled to surgery or any other procedure that according to the judgement of the investigator will interfere with the planned study procedures 10. Subjects with known previous major cerebral diseases (traumatic or non-traumatic) with permanent neurological deficits (i.e. subjects with a pre-injury modified Rankin Score of 3 or higher) 11. Known history of hypercoagulable state and/or thromboembolism (e.g. ischemic stroke, DVT, PE or AMI) 12. Known thrombocytopenia (thrombocytes < 50 x 10 x9/l) 13. Known current use of vitamin K-antagonists unless INR < 1.4 14. Pregnancy 15. Known or suspected allergy to trial product or related products 16. Previous participation (randomised) in this trial 17. Known receipt of any investigational drug within 30 days prior to this trial 18. Any other condition which, in the judgement of the investigator, might increase the risk to the subject or preclude the satisfactory ability to collect experimental data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of NovoSeven® in subjects with brain contusions.;Secondary Objective: To evaluate the preliminary efficacy of NovoSeven® in preventing early haemorrhagic progression in brain contusions.;Primary end point(s): The occurrence of all reported serious adverse events within the first 15 days after contusive brain injury. | — |
Countries
Finland, Italy, Spain
Outcome results
None listed