Ongoing and recently 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 5:38-45). Secondary analysis is ongoing and various additional manuscripts in preparation, including analysis of screening logs, observer variation in outcome assessment, and consent procedures. EBIC liaison officers: Nino Stocchetti, Gordon Murray, Andrew Maas.

  Novo Nordisk: A Phase II study on recombinant factor VIIa in brain contusion. Endorsed by EBIC. Completed in April 2006. EBIC liaison officers: Franco Servadei, Andrew Maas.

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.

Intradural Lesion Survey: coordinated by Franco Servadei. Over a three month period data on 729 patients with intradural posttraumatic mass lesions were collected (Neurosurgery. 2005 Dec; 57(6):1183-92).

The Impact Study: Many of the EBIC coordinated studies have been included in the IMPACT-database which currently contains data on 9205 patients from eight clinical trials and three prospective surveys. Andrew Maas was awarded a grant from NIH for a collaborative study, together with Tony Marmarou (Richmond, US) and Gordon Murray (Edinburgh, UK) on clinical trial design and analysis on traumatic brain injury. 

New studies

  Vasopharm: A Phase II trial on the new neuroprotective agent VAS203. The clinical protocol, study plans and Case Record Form are currently being designed in collaboration between Vasopharm and EBIC. EBIC liaison officers: Juan Sahuquillo, John Stover, Nino Stocchetti, Gordon Murray, Andrew Maas.

  EBIC Core Data Survey: The EBIC Executive is currently developing the protocol and CRF for a new Core Data Survey. Plans are to initiate a 3 month prospective data collection on severe and moderate TBI in all EBIC centers. Start of the survey is foreseen for early 2007. Possibilities for extending the survey to the Peoples Republic of China are being explored. Preliminary discussions on the possible clinical development of novel neuroprotective agents in collaboration with EBIC are currently ongoing with a number of pharmaceutical companies.