Completed studies

• Pharmos:
  Dexanabinol Study (n=861) completed in March 2004. This study showed the lowest overall mortality in severe head injury yet reported. Unfortunately no beneficial effect of Dexanabinol was found. Trial results were reported (Lancet Neurol 2006; 5:38-45). Various additional manuscripts have resulted from the study:
  
  • Differences in completion of screening logs between Europe and the United States in an emergency phase III trial resulting from HIPAA requirements
    Slieker FJ, Maas AI, Kompanje EJ, Stocchetti N.
    Ann Surg. 2005 Feb; 241(2):382-3.
  • Observer variation in the assessment of outcome in traumatic brain injury: experience from a multicenter, international randomized clinical trial
    Wilson JT, Slieker FJ, Legrand V, Murray G, Stocchetti N, Maas AI.
    Neurosurgery. 2007 Jul;61(1):123-8; discussion 128-9.
• Novo Nordisk:
  A Phase II study on recombinant factor VIIa in brain contusion. Endorsed by EBIC. Completed in April 2006.
  
  • Traumatic Intracerebral Hemorrhage Study Group., Progression of traumatic intracerebral hemorrhage: a prospective observational study
    Narayan RK, Maas AI, Servadei F, Skolnick BE, Tillinger MN, Marshall LF
    J Neurotrauma. 2008 Jun;25(6):629-39.
• Solvay Pharmaceuticals:
  A Randomized, Double blind, Placebo-Controlled Phase 2a Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic Brain Injury. Unfortunately this study was prematurely ended in 2010 following a takeover of Solvay Pharmaceuticals by Abbott Healthcare. Publication of the study results is in preparation.

Ongoing studies

• Brain IT:
  EBIC is a partner in the Brain IT project coordinated by Ian Piper (Glasgow).
  EBIC liaison officers: Juan Sahuquillo, Gordon Murray.
• Rescue ICP:
  A study on decompressive craniectomy initiated in the UK by Peter Hutchinson (Cambridge). The aim of this trial is to determine the effectiveness of an operation (decompressive craniectomy), compared to medical management alone, to treat brain swelling and improve outcome. Now expanding.
  EBIC liaison officers: Juan Sahuquillo, Franco Servadei, Andreas Unterberg, David Menon.
• The Impact Study:
  The IMPACT Study group was initiated in 2003 as an international collaborative venture supported by the US National Institutes of Health, involving methodological, statistical and clinical expertise. Access was granted to individual patient data of initially eight randomized controlled trials and three observational studies including a total of 9205 patients. During the continuation funding period (2007-2011) more studies were included, providing access to data of over 40 000 patients. The IMPACT studies aimed to develop recommendations for improving the design and analysis of trials in TBI.
• BHR Pharma:
  "A Randomized, Double Blind, Placebo Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients with Severe Traumatic Brain Injury", also known as the SyNAPSe Study (Study of the Neuroprotective Activity of Progesterone in Severe Traumatic Brain Injuries).

New studies

• NeuroVive Pharmaceuticals AB:
  European multicenter clinical trial on NeuroSTAT©. The active ingredient of NeuroSTAT© is cyclosporine-A which is considered a promising neuroprotective agent with a number of putative mechanisms, including mythocondrial protection.