The primary objective of the trial is to evaluate the safety of NovoSeven®/NiaStase® in patients with brain contusions. The secondary objective of the trial is to evaluate the preliminary efficacy of NovoSeven®/NiaStase® in preventing early haemorrhagic progression in contusive brain injury.

Condition	Intervention	Phase
Contusion	Drug: NovoSeven	Phase II

Further Study Details: 

Primary Outcomes: Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven/NiaStase) in Subjects with Brain Contusions
Expected Total Enrollment:  78

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Ages Eligible for Study: 18 Years - Years

Please refer to this study by ClinicalTrials.gov identifier  NCT00123591

Novo Nordisk Clinical Trial Call Center      866-867-7178 

Canada, Alberta
      Calgary,  Alberta,  T2N 2T9,  Canada; Recruiting
      Edmonton,  Alberta,  T6G 2B7,  Canada; Recruiting
Canada, British Columbia
      Vancouver,  British Columbia,  V5Z 1M9,  Canada; Recruiting
Canada, Manitoba
      Winnipeg,  Manitoba,  R3A 1R9,  Canada; Recruiting
Canada, Ontario
      Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting
      Toronto,  Ontario,  M5B 1W8,  Canada; Recruiting
      Ottawa,  Ontario,  K1Y 4E9,  Canada; Recruiting
      Hamilton,  Ontario,  L8L 2X2,  Canada; Recruiting
Canada, Quebec
      Montreal,  Quebec,  H4J 1C5,  Canada; Recruiting
      Montreal,  Quebec,  H3G 1A4,  Canada; Recruiting
      Greenfield Park,  Quebec,  J4V 2H1,  Canada; Recruiting

Study ID Numbers:  F7CBI-1600
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 22, 2005
ClinicalTrials.gov Identifier:  NCT00123591
Health Authority: Canada: Health Canada; United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26